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.
This recall has been terminated (originally issued April 27, 2009).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- January 29, 2009
- Posted
- April 27, 2009
- Terminated
- October 20, 2010
- Recall Number
- Z-1200-2009
- Quantity
- 497 kits, 93L
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The R1 reagent has microbial contamination.
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.
Lot / Code Info
Lot Number: 810703, exp. 10/09.
Root 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.