Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitative determination of ALT in s
FDA device recall Z-1529-2014 · posted 2014-04-30 · Terminated
Recall details
- Recalling firm
- Alfa Wassermann, Inc.
- Reason for recall
- Extremely low absorbance readings.
- Action taken
- 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 affected product and complete and submit the enclosed Product Response Form. For questions or concerns, contact the Alfa Wassermann Diagnostic Technologies, LLC Customer Solution Center, Toll Free: (866) 419-ALFA (2532).
- Root cause
- Process control
- Status
- Terminated
- Product code
- CKA
- Quantity affected
- 731 Kits
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-03-05
- Date posted
- 2014-04-30
- Date terminated
- 2015-08-13
- Location
- West Caldwell, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT (K131351) | Alfa Wassermann Diagnostic Technologies, LLC | 2013-08-15 |