Recall Z-0220-2009 ยท CFR Hexokinase, Glucose
Pointe Scientific, Inc.
Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)
| Date | Oct 31, 2008 (initiated Sep 10, 2008) |
| Status | Terminated |
| Reason | The inability of the product to maintain stated performance specifications through the stated shelf life. |
| Root cause | Process control |
| 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. |
| Quantity | 4 |
| Distribution | Nationwide, Canada, China, Romania and Trinidad. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002199 | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET Pointe Scientific, Inc.,, Nov 20, 2000 |