Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum,
FDA device recall Z-1117-2008 · posted 2008-05-22 · Terminated
Recall details
- Recalling firm
- Pointe Scientific, Inc.
- Reason for recall
- Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms.
- Action taken
- Pointe Scientific notified consignees via Urgent Medical Device Recall letters dated 12/14/07, instructed to dispose of the product and to send back a reply form to request replacement product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CKA
- Quantity affected
- 955 for all products.
- Distribution
- Worldwide Distribution - USA, Bolivia, Canada, Chile, China, Cyprus, Greece, Indonesia, Israel, Korea, Mexico, Pakistan, Panama, Peru, Philippines, Republic of Yemen, Russia, South Africa, Trinidad, U
- Date initiated
- 2007-12-14
- Date posted
- 2008-05-22
- Date terminated
- 2008-09-15
- Location
- Canton, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIQUID ALT(SGPT) REAGENT SET (K941287) | Pointe Scientific, Inc., | 1994-05-03 |