Pointe Scientific Liquid Glucose (HEXO) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG920-1200, HG920-250
FDA device recall Z-0222-2009 · posted 2008-10-31 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- The inability of the product to maintain stated performance specifications through the stated shelf life.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CFR
- Quantity affected
- 37
- Distribution
- Nationwide, Canada, China, Romania and Trinidad.
- Date initiated
- 2008-09-10
- Date posted
- 2008-10-31
- Date terminated
- 2009-11-27
- Location
- Canton, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET (K002199) | Pointe Scientific, Inc., | 2000-11-20 |