Alfa Wassermann ACE AST Reagent Recalled for Low Absorbance Readings
Alfa Wassermann is recalling specific lots of ACE AST Reagent because they produce extremely low absorbance readings, which may affect clinical test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving potential diagnostic errors without confirmed harm.
Plain-English summary
Alfa Wassermann, Inc. is recalling specific lots of ACE AST Reagent. The affected products are used in clinical laboratories and physician office laboratories for the quantitative determination of AST in serum and lithium heparin plasma using ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems.
The recall is due to extremely low absorbance readings. The specific lots involved are SA1047 (Lot F3609) and RX1047 (Lot F3610). The source text does not specify the total number of units recalled, the exact distribution dates, or the number of facilities affected, though it notes US Nationwide Distribution.
Consumers and laboratory personnel should stop using the affected lots and contact Alfa Wassermann for further instructions or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitative determination of AST 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
- Manufacturer
- Alfa Wassermann, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Alfa Wassermann, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Alfa Wassermann, Inc.
See all →- ModerateAlfa Wassermann ACE ALT Reagent Recalled for Low Absorbance Readings
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