CLASS II Device recall · Reported 1 May 2013 · FDA Enforcement Report
The Alere Cholestech LDX¿ high sensitivity C-Reactive recalled
Alere San Diego is recalling The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette, distributed nationwide in the US. The recall was initiated on 6 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1178-2013
- FDA event ID
- 64701
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2013
- FDA classified
- 25 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- E. coli
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Mar 2013 | Recall initiated by company | |
| 25 Apr 2013 | Classified by FDA | +50 days |
| 1 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide Distribution
Questions about this recall
Is The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette recalled?
Yes. Alere San Diego recalled The Alere Cholestech LDX¿ high sensitivity C-Reactive Protein (hsCRP) Test Cassette on 6 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1178-2013.
Why was it recalled?
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.
Which lots are affected?
Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13
Where was it sold?
USA Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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