Recall Z-0223-2009
Pointe Scientific, Inc. · initiated September 10, 2008
Product
Glucose (HEX) Hitachi; 3-HG920-L. (Clinical chemistry)
Codes / lots: Lot 727501.
Reason for recall
The inability of the product to maintain stated performance specifications through the stated shelf life.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0223-2009
- Initiated
- September 10, 2008
- Posted by FDA
- October 31, 2008
- Terminated
- November 27, 2009
- Product code
- CFR – Hexokinase, Glucose
- Quantity
- 63
- Distribution
- Nationwide, Canada, China, Romania and Trinidad.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0219-2009 | Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0220-2009 | Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0221-2009 | Pointe Scientific Liquid Glucose HEX Reagent Set, Pointe Scientific, Inc, Canton, MI…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0222-2009 | Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI…The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |
| Z-0224-2009 | Glucose HEX Reagent; HG920-SAM-911. (Clinical chemistry)The inability of the product to maintain stated performance specifications through the stated shelf life. | 09/10/2008Terminated |