Z-2046-2020Class II

BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 -

Name: Z-2046-2020 BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 -
Creator: Becton Dickinson & Co.
Published: 2020-04-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2020-04-14 / Terminated

FDA source

Becton Dickinson & Co. began a recall of BD BBLTM Gram Crystal Violet 250mL-- IVD Primary stain for Staining Microorganisms, Catalog Number: 212525 - Product Usage: Gram Stain Kits and Reagents are... on 2020-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2046-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-14
Posted: 2020-05-19
Terminated: 2022-02-10
Recalling firm: Becton Dickinson & Co
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.
Product code: JTS Stains, Microbiologic
Reason for recall: 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
FDA root cause: Under Investigation by firm
Action: BD issued Urgent Medical Device Notification to Customers/Distributors on 4/14/20 via FedEX stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog and lot numbers listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form. Even if you do not have any of the affected lots in your inventory, please complete the Customer Recall Response Form indicating you have zero (0) quantity and return as indicated above. Distributors requested to provide customer list to BD. BD will provide a product replacement for all discarded inventory. BD Customer/Technical Support 800-638-8663, Monday Friday between 7:00am and 7:00pm (EST) in the United States. For customers outside the United States, contact your local BDrepresentative or distributor. On 5/12/20 firm expanded the recall to an additional six (6) lots of product.
Quantity in commerce: 10,568 bottles
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, Taiwan, Hong Kong, Chile, EMEA, Thailand, China, Japan, Australia, New Zealand, Korea, Costa Rica, Mexico, Canada, and Singapore.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2046-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2046-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-19
Z-2047-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-19
Z-2048-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-19

Product code JTS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)