Drug recall
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic…
FDA recall event 71229 · Class III · Biocare Medical, LLC
Key facts
| Event ID | 71229 |
|---|---|
| Recall numbers | Z-1676-2015 |
| Recalling firm | Biocare Medical, LLC |
| Product type | Devices |
| Products | D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. |
| Initiation date | May 6, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Jun 4, 2015 |
| 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: