Alere San Diego, Inc. Recall: Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma
Alere San Diego, Inc. Recall: Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Alere San Diego, Inc.; Product: Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a
| Recalling firm | Alere San Diego, Inc. |
|---|---|
| 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. |
| Reason for recall | The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect. |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| Distribution | US |
| Recall initiated | 20160622 |
| Recall number | Z-2265-2016 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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