Drug recall
Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml…
FDA recall event 72160 · Class II · Biocare Medical, LLC
Key facts
| Event ID | 72160 |
|---|---|
| Recall numbers | Z-0252-2016 |
| Recalling firm | Biocare Medical, LLC |
| Product type | Devices |
| Products | Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typically expected to be negative for SMA. |
| Initiation date | Sep 8, 2015 |
| Report date | Nov 18, 2015 |
| Termination date | Jan 11, 2016 |
| City | Concord |
| State | CA |
| Country | United States |
| FEI number | 3004140393 |
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: