Alere Recalls Mononucleosis Rapid Test Devices Due to False Negative Risk
Alere San Diego is recalling 78 kits of the Clearview Mononucleosis Cassette because the positive control may produce false negative results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Alere San Diego, Inc. is recalling 78 kits of the IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma), also known as the Clearview Mononucleosis Cassette. The recall is being conducted because the positive control included in the rapid test may produce false negative results.
The affected units are identified by control lot number 11030386 and lot/unit codes MON1040008 and MON1040016. The products were distributed nationwide, including in Tennessee, Washington, Utah, Kansas, Kentucky, Minnesota, Georgia, Massachusetts, Pennsylvania, New York, Vermont, and the District of Columbia.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Users should check their inventory for the specific lot numbers listed and stop using the affected test kits.
The recalled product
- Product
- IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The MONO test (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of Infectious Mononucleosis heterophile antibodies in whole blood to aid in the…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 78
Distribution
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