Alere Cholestech LDX ALT AST Test Cassette Recalled for Humidity Impact
Alere San Diego is recalling 38,571 ALT AST test cassettes because humidity changes may impact test results.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential impact on test accuracy due to environmental factors, which aligns with the criteria for a moderate severity score involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Alere San Diego, Inc. is recalling 38,571 units of the Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. This product is used for the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
The recall was initiated because the manufacturer identified that humidity changes have the potential to impact results for certain analytes on the Alere Cholestech LDX System. The affected units were distributed nationwide in the United States and in Canada, South Africa, the Netherlands, Italy, Brazil, Singapore, Russia, Hong Kong, Argentina, South Korea, the Philippines, El Salvador, Indonesia, and Trinidad.
Healthcare providers and consumers should stop using the affected cassettes and contact Alere San Diego for instructions on return or replacement. Specific lot codes for the recalled units are listed in the official recall documentation.
The recalled product
- Product
- Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 38,571
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 (20)
- Lot/Unit Codes: 274351A
- 274351B
- 274352B
- 274353A
- 290243A
- 290244A
- 290641A
- 290641B
- 290642A
- 290643A
- 290643B
- 290644A
- 290644B
- 290645A
- 290645B
- 290646A
- 290647A
- 290648A
- 293669A
- 293670A
Distribution
Distributed nationwide across the United States.
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