Product Name : ( Phosphorus Reagent )
List Number : (7D71-22);
Lot numbers : ( 64736UN12 , 03991UN13, 51611UN13 )
List Number : ( 7D71-31 );
Lot Numbers : ( 74805UN12, 03992UN13 )
Correct dates : ( see attached )
6C29-22, 6C29-27, 6C30-22, 6C30-27, 8P26-32
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NCMDR Update Code:
Multiple Lot numbers of the affected devices are provided in the attached FSN.
ARCHITECT Intact PTH Assay List Number 8K25 (see attached for impacted lots) Reagents (8K25-20, 8K25-25, 8K25-27), Calibrators (8K25-01) and Controls (8K25-10).
More information on the affected products is provided in the attached letter
- 7K61-35 lot 53921UI00 (Expiry 20 March 2016)
- 7K61-25 lot 50957UI00 (Expiry 17 January 2016)
- 7K61-35 lot 50956UI00 (Expiry 17 January 2016)
- UDI Number- Not applicable
FreeStyle Flash Blood Glucose Meter
FreeStyle Blood Glucose Meter
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FDA update code:
Part number CAT11001-0; all serial numbers
Catalog Number 17002 NDC 99073-0170-02. All serial numbers
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MHRA update code :
- FreeStyle Mini blood glucose meter
- FreeStyle Navigator (Version 1.0 and 1.5)
List Number : 8L44-25 Lot Number : 42072LI00 Expiration Date 28-May-2015
List Number : 8L44-25 Lot Number : 42072LI01 Expiration Date : 28-May-2015
List Number : 8L44-25 Lot Number : 42253LI00 Expiration Date : 30-Jun-2015
List Number : 8L44-25 Lot Number : 42253LI01 Expiration Date : 30-Jun-2015
List Number : 8L44-30 Lot Number : 42255LI00 Expiration Date : 30-Jun-2015
List Number : 8L44-30 Lot Number : 42255LI01 Expiration Date : 30-Jun-2015
List Number : 8L44-35 Lot Number : 42256LI00 Expiration Date : 30-Jun-2015
List Number : 09H46-02
Lot Number : 6853, 6901, 6953
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BfArM update codes :
List Number : Lot Number
09H46-02 : 6991
09H46-02 : 7024
09H46-02 : 7027
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BfARM update code :
List Number : Lot number;
09H46-02 : 7044
09H46-02 : 7082
09H46-02 : 7110
09H46-02 : 7119