Alere Cholestech LDX ALT AST Test Cassette — Class II medical device recall Z-1139-2013
Terminated recall by Alere San Diego, Inc., reported 2013-04-24, distributed nationwide. The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette,
| Recall number | Z-1139-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alere San Diego, Inc., San Diego, CA, United States |
| Recall initiated | 2013-03-06 |
| Classified | 2013-04-17 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2013-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, HK, ID, IT, KR, NL, PH, RU, SG, SV, TT, ZA |
| Quantity | 38,571 kits |
| Model numbers | 12-788 |
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).
Reason for recall
The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1139-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.