Alere San Diego Recalls Mono Rapid Test Devices Due to Labeling Error
Alere San Diego is recalling Henry Schein One Step + Mono Rapid Test Devices 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 is defined as unlikely to cause adverse health consequences. The issue is a documentation and labeling error rather than a functional defect or contamination.
Plain-English summary
Alere San Diego, Inc. is recalling the Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070. This medical device is a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum, or plasma.
The recall is being conducted because the product labeling and packaging contain incorrect information regarding the positive control. Specifically, the labeling incorrectly references human plasma as the antibody material. The source text does not indicate that the actual test components are contaminated or that the test results are compromised, only that the descriptive text in the packaging is inaccurate.
The recall affects all lots of the product. Consumers and healthcare providers should stop using the affected test devices and contact the recalling firm for further instructions or a replacement.
The recalled product
- Product
- Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of bovine erythrocytes to qualitatively and selectively detect IM heterophile antibodies in whole blood, serum or plasma in just minutes.
- 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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