Drug recall
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad…
FDA recall event 68016 · Class II · Bio-Rad Laboratories, Inc.
Key facts
| Event ID | 68016 |
|---|---|
| Recall numbers | Z-1537-2014 |
| Recalling firm | Bio-Rad Laboratories, Inc. |
| Product type | Devices |
| Products | Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used. |
| Initiation date | Apr 8, 2014 |
| Report date | May 14, 2014 |
| Termination date | May 30, 2014 |
| City | Hercules |
| State | CA |
| Country | United States |
| FEI number | 2915274 |
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: