Recall Z-1529-2014 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
Alfa Wassermann, Inc.
Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera and ACE Axcel Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office labs.
| Date | Apr 30, 2014 (initiated Mar 5, 2014) |
| Status | Terminated |
| Reason | Extremely low absorbance readings. |
| Root cause | Process control |
| Action | Alfa Wassermann Diagnostic Technologies, LLC issued an "Important: Advisory Notice/"Product Response Form" dated March 5, 2014 and sent on March 6, 2014 to their customers for ACE ALT Reagent Product reorder number SA1046 Lot F3604. They issued a follow-up "Important: Advisory Notice/"Product Response Form" dated March 21, 2014 and sent on March 26, 2014 to their customers for ACE AST Reagent Product reorder numbers SA1047, Lot F3609, and RX1047, Lot F3610. The notification identified the product(s), problem, and actions to be taken by the customers. Customers were instructed to destroy any |
| Quantity | 731 Kits |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131351 | ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT Alfa Wassermann Diagnostic Technologies, LLC, Aug 15, 2013 |