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.
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 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.
Related recalls
Same manufacturer · Alere San Diego, Inc.
See all →- HighAbbott Cholestech LDX Battery Kit Recall: Potential Swelling Risk
FDA (Devices) · 2024-05-08
- ModerateCholestech LDX cholesterol test cassettes require bilirubin interference label update
FDA (Devices) · 2022-08-17
- LowAlere Cholestech LDX Analyzer Recalled for Reversed Power Supply Polarity
FDA (Devices) · 2019-09-11
- ModerateAlere Triage Drugs of Abuse Plus TCA 25 Test Kit Recalled for False Positives
FDA (Devices) · 2018-02-07
- ModerateAlere Triage Total 5 Control Level 1 Recalled for Incorrect Ranges
FDA (Devices) · 2016-11-23
Same hazard · inaccurate results
See all →- HighHealthmark Protein Test Recalled Due to Expired Ingredient
FDA (Devices) · 2026-09-02
- HighHardyDisk AST Cefiderocol 30µg for In Vitro Testing Recalled Due to Incorrect Cartridges
FDA (Devices) · 2026-08-12
- HighGEM Premier 7000 with iQM3 Blood Analysis Systems Recalled for Solution Concentration Issues
FDA (Devices) · 2026-08-12
- Highepoc BGEM BUN Test Card for epoc Blood Analysis System
FDA (Devices) · 2026-05-06
- HighAbbott i-STAT EG7+ Blood Gas Cartridges Reporting Inaccurate Results
FDA (Devices) · 2026-05-06