FDA Recall
Terminated
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
Recall: Z-0221-2009
·
Initiated September 10, 2008
Recall
- Recall Number
- Z-0221-2009
- Event Number
- 49466
- Firm
- Pointe Scientific, Inc.
- FEI Number
- 1827821
- Product Code
- CFR
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- September 10, 2008
- Posted
- October 31, 2008
- Terminated
- November 27, 2009
- Address
- 5449 Research Dr, Canton, MI, 48188
Description
Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG720-600 and HG920-756. (Clinical chemistry)
Reason
The inability of the product to maintain stated performance specifications through the stated shelf life.
Action
Consignees are being notified by letter dated 9/10/08 which will be sent out via fax, email or certified mail to all direct account and drop-ship customers. Customers are advised to dispose of any recalled product found and to consider test results obtained with these lots questionable. Contact Pointe Scientific, Inc. at 1-800-757-5313 or 1-734-487-8300 for assistance.
Distribution
Nationwide, Canada, China, Romania and Trinidad.
Quantity
10