Drug recall
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid…
FDA recall event 49026 · Class III · Alere San Diego, Inc.
Key facts
| Event ID | 49026 |
|---|---|
| Recall numbers | Z-1344-2013 |
| Recalling firm | Alere San Diego, Inc. |
| Product type | Devices |
| Products | Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box… |
| Initiation date | Jan 21, 2013 |
| Report date | May 29, 2013 |
| Termination date | Aug 28, 2013 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 1000125596 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: