Recall Z-0171-2009 ยท CIT Nadh Oxidation/Nad Reduction, Ast/Sgot
Pointe Scientific, Inc.
Liquid AST (SGOT) Reagent Set, Manufactured by Pointe Scientific, Inc., Canton, MI in 150 ml (Product no. A7561-150) and 450 ml (Product no A7561-450). For the quantitative determination of aspartate amoinotransferase in human serum
| Date | Oct 22, 2008 (initiated Aug 25, 2008) |
| Status | Terminated |
| Reason | The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results. |
| Root cause | Material/Component Contamination |
| Action | Consignees were notified via recall letter dated 8/22/08 and mailed 8/25/08 to examine their inventory, dispose of any recalled product found, and to notify the firm for replacements. Contact Pointe Scientific Inc., at 1-800-757-5313 for assistance. |
| Quantity | 109 kits |
| Distribution | Nationwide, Bolivia, Ecuador, Greece, Indonesia, Mexico, Nepal, Philippines, Romania and Serbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941132 | LIQUID AST (SGOT)REAGENT SET Pointe Scientific, Inc.,, May 2, 1994 |