Recall Z-1201-2009
Pointe Scientific, Inc. · initiated January 29, 2009
Product
Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc., Canton, MI, Catalog Numbers: 10-H7545-80, 12-H7545-162, 3-H7545-L, 7-H7545-1000, 7-H7545-320, 7-H7545-40, 7-H7545-80, H7545-1000, H7545-320, H7545-40, H7545-80, HH945-240 and HH945-480. The product is used for In vitro diagnostic for the quantitative determination of high-density lipoprotein cholesterol in human serum or plasma.
Codes / lots: Lot Number: 818202, exp. 12/09.
Reason for recall
The R1 reagent has microbial contamination.
FDA-determined cause: Nonconforming Material/Component
Action taken
Consignees were notified by "Urgent: Medical Device Recall" letter dated January 29, 2009, to conduct the recall to the retail level, to examine inventory and dispose of affected stocks on hand, and to complete the "Recall Return Response Form". Consignees were instructed to return their completed forms via mail, fax (1-734-483-1592) or e-mail to Pointe Scientific, Inc. (PS). Direct questions about the recall to PS Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Details
- Recall number
- Z-1201-2009
- Initiated
- January 29, 2009
- Posted by FDA
- April 27, 2009
- Terminated
- October 20, 2010
- Product code
- LBR – Ldl & Vldl Precipitation, Hdl
- Quantity
- 717 kits, 164L
- Distribution
- Worldwide Distribution -- US, Chile, Dominican Republic, Egypt, Ghana, Greece, India, Israel, Italy, Jamaica-West Indies, Korea, Malaysia, Mexico, Philippines, Poland, Romania, Serbia, Trinidad-West Indies, Turkey and Venezuela.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1200-2009 | Pointe Scientific Liquid Auto HDL Cholesterol Reagent Set, Pointe Scientific, Inc.…The R1 reagent has microbial contamination. | 01/29/2009Terminated |