The Recall Desk
ModerateFDA (Devices)·Z-1178-2013·Announced 2013-05-01

Alere Cholestech LDX hsCRP Test Cassette Recall for Imprecision

Alere San Diego, Inc. is recalling 2,333 Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassettes due to increased imprecision that may affect quantitative 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, and the source text describes a performance issue (imprecision) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Alere San Diego, Inc. is recalling 2,333 units of the Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. The affected products are distributed nationwide in the United States. The recall involves specific lot numbers 274632 and 281847, with expiration dates of May 5, 2013, and June 30, 2013.

The recall was initiated because the test cassettes may have increased imprecision relative to the performance data provided in the package insert. This issue may cause differences in quantitative results for hsCRP when compared to a reference method or when repeat testing is performed on the same patient sample.

The Alere Cholestech LDX hsCRP is an in vitro diagnostic test used for the quantitative determination of C-reactive protein in whole blood or serum. Consumers and healthcare providers should check their inventory for the specific model and lot numbers listed above and contact the manufacturer for further instructions.

The recalled product

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 di
Manufacturer
Alere San Diego, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
2,333

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 (4)

  • Model Number 12-807. ¿ Lot/Unit Codes: 274632
  • 281847 ¿ Expiration date
  • or Expected shelf life: 5/5/13
  • 6/30/13

Distribution

Distributed nationwide across the United States.

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