Recall Z-1111-2008 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Pointe Scientific, Inc.
Pointe Scientific Liquid ALT (SGPT) reagent set for the quantitative determination of alanine aminotransferase in serum, 450 ml, Catalog no. A7526-450, in vitro diagnostic, Pointe Scientific, Inc.; Canton, MI 48188
| Date | May 22, 2008 (initiated Dec 14, 2007) |
| Status | Terminated |
| Reason | Failure of the reagent to produce test results. The R1 reagent may be contaminated with microorganisms. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 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, Ukraine and West Indies. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941287 | LIQUID ALT(SGPT) REAGENT SET Pointe Scientific, Inc.,, May 3, 1994 |