FDA Device recall Z-2046-2020
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits… by Becton Dickinson And, citing may exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram sta….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2046-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-14 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Becton Dickinson And |
| Distribution | US |
Product
BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Reason
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
Identifiers
| code_info | Lot Number/ Exp Date: 9269800 04/30/21; 9296589 05/31/21; 9317733 06/30/21; 9352487 07/31/21; Expanded 05/12/2…Lot Number/ Exp Date: 9269800 04/30/21; 9296589 05/31/21; 9317733 06/30/21; 9352487 07/31/21; Expanded 05/12/20- Lot Numbers: 9352484 07/31/21 9352492 07/31/21 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2046-2020%22
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