FDA Device recall Z-1178-2013
The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807
- FDA Device
- Class II
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class II recall of The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807 by Alere San Diego, citing 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 quantita….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1178-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-06 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1178-2013%22
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