Cytyc Prenatal Products/Hologic Inc.

Products made between 08/06/2009 and 11/25/2009 Table 1: Catalog Numbers and Manufacturing Lots (with date of manufacture and expiration date) Specimen Collection Kits (8-pack) Expiration Date 02/08/09 03/08/09 03/08/09 10/31/08 03/22/09 02/28/09 04/05/09 04/17/09 06/07/09 06/29/09 08/06/09 06/30/09 06/30/09 09/21/09 11/01/09 01/11/10 03/07/10 04/15/10 OS/24/10 07/25/10 08/26/10 09/23/10 10/01/10 10/11/10 11/28/10 12/20/10 02/10/11 02/10/11 02/10/11 02/21/11 03/10/11 04/01/11 05/05/11 Catalog Number Lot 00797 B6025 00797 C6030 00797 C6029 00797 C6085 00797 C6086 00797 C6108 00797 D6016 00797 D6058 00797 F6032 00797 F6126 00797 H6004 00797 H6096 00797 H6096 00797 J6092 00797 1<6061 00797 A7041 00797 (7032 00797 D7051 00797 E7062 00797 G7075 00797 H7046 00797 J7060 00797 J7081 00797 K7045 00797 L7081 00797 9422846 00797 9422920 00797 9422920 00797 9422920 00797 9422967 00797 9422978 00797 9423020 00797 9423065 Quantity 8320.00 2692.00 372.00 787.00 1560.00 2392.00 2584.00 12113.00 11975.00 12015.00 12158.00 6.00 9172.00 12005.00 12171.00 11915.00 13302.00 13104.00 13045.00 11869.00 6119.00 5840.00 3000.00 8826.00 12050.00 12212.00 1066.00 10000.00 11066.00 1156.00 12136.00 10558.00 13150.00 Date of Manufacture 02/09/06 03/09/06 03/09/06 03/22/06 03/23/06 03/30/06 04/06/06 04/17/06 06/07/06 06/30/06 08/04/06 08/24/06 08/25/06 09/21/06 11/01/06 01/12/07 03/08/07 04/16/07 OS/25/07 07/26/07 08/27/07 09/24/07 10/02/07 10/12/07 11/29/07 12/21/07 02/11/08 02/11/08 02/11/08 02/22/08 03/10/08 04/01/08 05/05/08 3 00797 9423065 68.00 OS/20/08 00797 9423137 6004.00 OS/29/08 00797 9423390 6283.00 10/14/08 00797 9423461 6892.00 11/13/08 00797 9423472 13299.00 12/11/08 Specimen Collection Kit (2S-pack) Catalog Date of Number Lot Number Quantity Manufacture 71738-001 9423548 334.00 12/22/08 71738-001 9423548 666.00 01/19/09 71738-001 9423596 3173.00 3/11/2009 71738-001 9423700 4274.00 5/4/2009 71738-001 9423802 4912.00 5/14/2009 71738-001 9423855 4249.00 6/18/2009 71738-001 9423900 3850.00 6/24/2009 71738-001 9423987 4244.00 8/19/2009 71738-001 9424062 3883.00 9/11/2009 71738-001 9424139 3868.00 10/15/2009 Rapid fFN Cassette Kit (26-pack) Catalog Date of Number Lot Quantity Manufacture 01200 K7115 812.00 11/27/07 01200 L7041 749.00 12/11/07 01200 L7076 746.00 12/18/07 01200 M7076 504.00 01/18/08 01200 A8029 792.00 01/29/08 01200 A8060 818.00 02/04/08 01200 A8088 204.00 02/07/08 01200 A8105 566.00 02/12/08 01200 88013 415.00 02/22/08 01200 88013 449.00 02/29/08 01200 88075 852.00 03/06/08 01200 C8010 805.00 03/21/08 01200 C8048 564.00 03/26/08 01200 C8077 863.00 04/11/08 01200 08019 904.00 04/24/08 01200 08072 387.00 04/30/08 01200 08040 1107.00 OS/21/08 OS/20/11 OS/29/11 10/14/11 11/13/11 12/11/11 Expiration Date 11/30/2011 11/30/2011 11/30/2011 12/31/2011 11/30/2011 1/31/2012 5/31/2012 1/31/2012 6/30/2012 7/31/2012 Expiration Date OS/27/09 06/10/09 06/17/09 07/18/09 07/31/09 08/04/09 08/07/09 08/12/09 08/22/09 08/29/09 09/04/09 09/19/09 09/24/09 10/10/09 10/23/09 10/29/09 11/19/09 4 Catalog Date of Expiration Number Lot Quantity Manufacture Date 01200 08040 4.00 OS/22/08 11/19/09 01200 E8021 819.00 OS/23/08 11/21/09 01200 E8021 106.00 OS/27/08 11/21/09 01200 E8055 1001.00 06/18/08 12/17/09 01200 F8026 460.00 06/23/08 12/22/09 01200 F8026 595.00 06/23/08 12/22/09 01200 F8045 810.00 07/14/08 12/31/09 01200 F8045 205.00 07/15/08 12/31/2009 01200 G8020 270.00 07/25/08 1/31/2010 01200 G8020 450.00 07/26/08 1/31/2010 01200 G8020 167.00 07/29/08 1/31/2010 01200 G8057 533.00 08/04/08 1/31/2010 01200 H8008 433.00 08/13/08 2/28/2010 01200 H8008 323.00 08/14/08 2/28/2010 01200 H8008 1.00 08/14/08 2/28/2010 01200 H8032 365.00 08/20/08 2/28/2010 01200 H8032 235.00 08/21/08 2/28/2010 01200 H8032 225.00 08/22/08 2/28/2010 01200 H8032 132.00 08/22/08 2/28/2010 01200 H8032 122.00 08/25/08 2/28/2010 01200 H8060 593.00 09/04/08 2/28/2010 01200 H8060 140.00 09/05/08 2/28/2010 01200 H8060 133.00 09/08/08 2/28/2010 01200 H8060 95.00 09/09/08 2/28/2010 01200 H8060 68.00 09/10/08 2/28/2010 01200 J8055 405.00 09/26/08 3/31/2010 01200 J8055 120.00 09/29/08 3/31/2010 01200 J8055 120.00 10/01/08 3/31/2010 01200 J8055 88.00 10/01/08 3/31/2010 01200 J8055 115.00 10/06/08 3/31/2010 01200 J8055 71.00 10/06/08 3/31/2010 01200 K8020 375.00 10/13/08 4/30/2010 01200 K8020 100.00 10/14/08 4/30/2010 01200 K8020 50.00 10/15/08 4/30/2010 01200 K8020 300.00 10/16/08 4/30/2010 01200 K8020 93.00 10/20/08 4/30/2010 01200 K8059 237.00 10/23/08 4/30/2010 01200 K8059 252.00 10/23/08 4/30/2010 5 Catalog Date of Expiration Number Lot Quantity Manufacture Date 01200 K8059 321.00 10/24/08 4/30/2010 01200 K8059 70.00 10/28/08 4/30/2010 01200 K8059 82.00 10/28/08 4/30/2010 01200 K8085 228.00 11/14/08 4/30/2010 01200 L8023 467.00 11/14/08 5/31/2010 01200 L8039 691.00 11/26/08 5/31/2010 01200 L8039 61.00 12/03/08 5/31/2010 01200 J8039 165.00 12/04/08 3/31/2010 01200 L8039 155.00 12/08/08 5/31/2010 01200 M8019 20.00 12/08/08 6/30/2010 01200 M8019 250.00 12/09/08 6/30/2010 01200 M8019 300.00 12/12/08 6/30/2010 01200 M8019 23.00 12/15/08 6/30/2010 01200 M8019 95.00 12/16/08 6/30/2010 01200 M8019 75.00 12/17/08 6/30/2010 01200 M8019 105.00 12/19/08 6/30/2010 01200 M8019 118.00 12/19/08 6/30/2010 01200 M8019 50.00 12/23/08 6/30/2010 01200 M8056 170.00 01/06/09 6/30/2010 01200 M8056 174.00 01/07/09 6/30/2010 01200 M8056 4.00 01/13/09 6/30/2010 01200 A9001 462.00 01/13/09 7/31/2010 01200 A9016 342.00 01/21/09 7/31/2010 01200 A9011 146.00 01/21/09 7/31/2010 01200 A9011 954.00 01/21/09 7/31/2010 01200 A9034 450.00 01/21/09 7/31/2010 01200 A9011 146.00 01/22/09 7/31/2010 01200 A9034 466.00 1/30/2009 7/31/2010 01200 A9047 722.00 2/17/2009 07/31/2010 01200 B9018 274.00 2/20/2009 08/31/2010 01200 B9033 794.00 3/3/2009 08/31/2010 01200 C9013 107.00 3/20/2009 09/30/2010 01200 C9023 106.00 3/25/2009 09/30/2010 01200 C9021 100.00 3/23/2009 09/30/2010 01200 C9035 169.00 3/11/2009 09/30/2010 01200 C9045 300.00 3/13/2009 09/30/2010 01200 C9055 246.00 3/17/2009 09/30/2010 01200 C9057 558.00 3/20/2009 09/30/2010 6 Catalog Date of Expiration Number lot Quantity Manufacture Date 01200 C9093 387.00 4/07/2009 09/30/2010 01200 09001 627.00 4/17/2009 10/31/2010 01200 09024 782.00 4/24/2009 10/31/2010 01200 09062 772.00 5/14/2009 10/31/2010 01200 E9005P 172.00 6/02/2009 11/30/2010 01200 E9010P 173.00 6/02/2009 11/30/2010 01200 E9019P 601.00 6/02/2009 11/30/2010 01200 E9055 818.00 6/08/2009 11/30/2010 01200 E9089 156.00 6/08/2009 12/31/2010 01200 F9008 169.00 6/09/2009 12/31/2010 01200 F9018 480.00 6/15/2009 12/31/2010 01200 F9043 941.00 6/25/2009 12/31/2010 01200 F9079 947.00 7/20/2009 12/31/2010 01200 G9034 138.00 7/20/2009 01/31/2011 01200 G9045 216.00 7/21/2009 01/31/2011 01200 G9075 555.00 08/06/2009 01/31/2011 01200 G9104P 105.00 9/18/2009 01/31/2011 01200 H9001P 126.00 9/18/2009 02/28/2011 01200 H9005P 107.00 9/18/2009 02/28/2011 01200 H9010 538.00 9/08/2009 02/28/2011 01200 H9030 95.00 8/27/2009 02/28/2011 01200 H9053 104.00 8/21/2009 02/28/2011 01200 H9061 199.00 9/01/2009 02/28/2011 01200 H9072 807.00 9/14/2009 02/28/2011 01200 J9023 1093.00 9/24/2009 03/31/2011 01200 J9036 444.00 9/30/2009 03/31/2011 01200 J9057 300.00 10/6/2009 03/31/2011 01200 K9008 461.00 10/21/2009 04/30/2011 01200 K9024 581.00 10/20/2009 04/30/2011 01200 K9042 527.00 10/29/2009 04/30/2011 01200 K9077 567.00 11/6/2009 04/30/2011 Rapid fFN Control Kit Catalog Date of Expiration Number lot Quantity Manufacture Date 01166 M7052 605.00 12/18/07 12/17/08 01166 B8001 611.00 02/07/08 02/06/09 01166 B8029 523.00 02/13/08 02/12/09 7 Catalog Number Lot 01166 C8001 01166 D8076 01166 D8084 01166 G8030 01166 K8058 01166 M8005 01166 C9026 01166 F9073 01166 F9075 01166 G90n 01166 G9100 01166 H9018 01166 H9034 01166 H9055 01166 K9049 01166 L9041 Catalog Lot 01175 M7062 01175 M7062 01175 B8116 01175 G8013 01175 A9003 01175 F9095 01175 J9025 01175 L9002 End ofTable 1 Quantity 76.00 444.00 834.00 1200.00 640.00 1199.00 1150.00 300.00 300.00 200.00 438.00 129.00 199.00 1000.00 567.00 644.00 TLiIQ QCette Quantity 174.00 7.00 400.00 500.00 400.00 356.00 100.00 511.00 Date of Manufacture 03/03/08 04/22/08 04/28/08 07/18/08 10/20/08 12/04/08 3/18/2009 6/22/2009 6/24/2009 7/29/2009 8/5/2009 8/7/2009 8/11/2009 9/1/2009 10/21/2009 11/17/2009 Date of Manufacture 01/10/08 01/11/08 03/04/08 07/10/08 01/09/09 7/9/09 9/18/09 11/18/09 Expiration Date 03/03/09 04/22/09 04/28/09 07/18/09 10/20/09 12/04/09 2/28/2010 6/30/2010 6/30/2010 6/30/2010 6/30/2010 7/31/2010 8/31/2010 8/31/2010 10/31/2010 11/30/2010 Expiration Date n/a n/a n/a n/a n/a n/a n/a n/a 8

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide distribution.

Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1202 TLiIQ Analyzer Boxed Set (includes Analyzer/Printer and QCette). manufactured by Hologic, Sunnyvale, CA. || Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in

Products made between 08/06/2009 and 11/25/2009

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide distribution.

Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 1175 TLiIQ QCette ; manufactured by Hologic, Sunnyvale, CA. || Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in

Products made between 08/06/2009 to 11/25/2009

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide distribution.

Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 71738 Specimen Collection Kit (25 pack); manufactured by Hologic, Sunnyvale, CA. || Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in

Products produced between 08/06/2009 and 11/25/2009.

Clinical Chemistry and Clinical Toxicology Devices

3

No

Worldwide distribution.

Rapid fFN for the TLi IQ system and specimen collection kit in the following configurations: 0797 Specimen Collection Kit (8 pack); manufactured by Hologic, Sunnyvale, CA. || Medical device for use in assessment of preterm birth risk. Enzyme Immunoassay, Fetal Fibronectin and Device for Specimen Collection (code LIO). The Rapid fFN test is approved for the indication to aid to rapidly assess the risk of preterm delivery in