[Recalled] 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 heterophi
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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. |
|---|---|
| Brand / manufacturer | Alere San Diego, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2265-2016 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 22 June 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Alere San Diego, Inc.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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