Alfa Wassermann ACE ALT Reagent Recalled for Low Absorbance Readings
Alfa Wassermann is recalling 731 kits of ACE ALT Reagent due to extremely low absorbance readings that may affect test accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is a performance issue (low absorbance) rather than a direct physical hazard like injury or death, fitting the Moderate category for a medical device with no reported injuries.
Plain-English summary
Alfa Wassermann, Inc. is recalling 731 kits of ACE ALT Reagent (Product reorder number SA1046 Lot F3604). The product is used for the quantitative determination of ALT in serum and lithium heparin plasma using ACE, ACE Alera, and ACE Axcel Clinical Chemistry Systems in clinical laboratories and physician office labs.
The recall was initiated because the reagent produced extremely low absorbance readings. This issue may compromise the accuracy of the test results.
The affected product was distributed nationwide in the United States. Users of the product should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Alfa Wassermann, Inc.
- Hazard
- Affected units
- 731
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ACE¿ ALT Reagent (Product reorder number SA1046 Lot F3604)
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
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