The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein — Class II medical device recall Z-1178-2013
Terminated recall by Alere San Diego, Inc., reported 2013-05-01, distributed nationwide. The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performanc
| Recall number | Z-1178-2013 |
|---|---|
| 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 | 2013-04-25 |
| Reported by FDA | 2013-05-01 |
| Terminated | 2014-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,333 kits |
| Model numbers | 12-807 |
Product
The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
Reason for recall
The Alere Cholestech LDX¿ hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.
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-1178-2013. 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.