Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, for the quantitative determination of glucose in serum, 5 x 600 m
FDA device recall Z-1326-06 · posted 2006-08-03 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Product does not meet performance specifications through its labeled expiration period.
- Action taken
- Customers were notified via recall letter dated 6/7/06 to cease using and to discard these lots, and to send back the recall response form for replacement stocks.
- Root cause
- Other
- Status
- Terminated
- Product code
- CFR
- Quantity affected
- 14 kits
- Distribution
- Worldwide, including USA, Canada, China, Panama, Russia and Trinidad.
- Date initiated
- 2006-06-07
- Date posted
- 2006-08-03
- Date terminated
- 2007-11-19
- 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 |