Alere Acceava Mono II Rapid Test Strip Labeling Recall
Alere San Diego is recalling Acceava Mono II Rapid Test Strips because the product labeling incorrectly identifies the positive control material as human plasma.
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 indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding the source of the control material.
Plain-English summary
Alere San Diego, Inc. is recalling the Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. This medical device is a mononucleosis rapid test that detects IM heterophile antibodies in whole blood, serum, or plasma.
The recall is due to a labeling error. The product labeling and packaging incorrectly state that the positive control information references human plasma as the antibody material. This description is incorrect.
The recall covers all lots of the product distributed in the United States. Consumers and healthcare providers should stop using the affected test strips and contact Alere San Diego, Inc. for further instructions or a return.
The recalled product
- Product
- Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma.
- Manufacturer
- Alere San Diego, Inc.
- Category
- Medical Device — Diagnostic Test
- Hazard
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 (1)
- all lots are affected
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 7 recalled by Alere San Diego, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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