Drug recall
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine…
FDA recall event 61769 · Class II · Becton Dickinson & Co.
Key facts
| Event ID | 61769 |
|---|---|
| Recall numbers | Z-2031-2012, Z-2032-2012 |
| Recalling firm | Becton Dickinson & Co. |
| Product type | Devices |
| Products | BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to…, Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for increase level of artifacts to appear as large, spherical and easy to distinguish or small & more difficult to distinguish from gram positive cocci. |
| Initiation date | Apr 12, 2012 |
| Report date | Jul 25, 2012 |
| Termination date | Dec 10, 2012 |
| City | Sparks |
| State | MD |
| Country | United States |
| FEI number | 1119779 |
At a glance
- 1–9 Products in this recall
- 10–99 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: