Device Recall Pointe Scientific

Catalog numbers: H7545-R1, 12-H7545-162, H7545-1000, HDL600 Lot number: 430402

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US including MI, FL, CA, TX, CT, PR and Internationally to Canada.

Pointe Scientific autoHDL Reagent H7545 || H7545-R1 in a bulk cube container or HDPE plastic bottle || H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 || 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 || HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 || Kits: HDPE plastic bottle, PP plastic caps. || Bulk: PE plastic cube containers, PP plastic caps. || Quantitative determination of high density lipoprotein cholesterol in human serum or plasma. In vitro diagnostic use only.

C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.

Pointe Scientific Creatinine Reagent || Catalog number C7539-150 || in vitro diagnostic || C7539-150 kit includes one R1 and one R2 bottle. || R1: HDPE plastic bottle. 120 ml fill. || R2: HDPE plastic bottle. 90 ml fill.

Lot: 505801 Expiration date: 2015-11 catalog numbers: G7583-CTL 7-G7583-CTL-L1 7-G7583-CTL-L2 7-G7583-CTL-L3

Hematology and Pathology Devices

2

No

Worldwide distribution: US (nationwide) including states of: PA, CA, KY, FL, NJ, DE, MI, MN,and IL; and countries of: United Arab Emirates, Austria, Italy, Israel, Greece, and Australia.

Pointe Scientific G6PD Controls || Kit configuration: 6 x 0.5 ml (2 vials each of Level 1, Level 2 and Level 3). || Also sold as individual vials || Bottle: Clear glass vials || Cap: Rubber seal with colored aluminum seals || Glucose-6-phosphate dehydrogenase (G6PD) controls can be used to test for the quantitative and qualitative determination of G6PD in blood.

Catalog # HB979-693 Lot #'s: 025903-012; 025903-278. Catalog # HB979-711 Lot #'s: 025903-009; 025903-079; 025903-080; 025903-102; 025903-278; 025903-355. Catalog # 7-HB979-R1-40 Lot #: 025903-055. Catalog # 12-HB979-192 Lot #'s: 025903-090; 025903-362.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE

Pointe Scientific Hitachi Total Bilirubin Rl Reagent || Product Usage: || Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

Catalog numbers: HA461, HA761 , HA961 and lot codes:022204, 034801, 102401, 119503, and 134101.

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution

Pointe Scientific Hitachi AST Reagent || R1 : PE plastic bottle w/PP plastic cap. || R2: PE plastic bottle w /PP plastic cap. || Product Usage: || Two Part Chemistry Reagent For the quantitative determination of Aspartate Aminotransferase (ASl) in human serum on Hitachi analyzers.