Z-1296-2025Class II

BD BBL TB Stain Kit K, Catalog (REF): 212522

Name: Z-1296-2025 BD BBL TB Stain Kit K, Catalog (REF): 212522
Creator: Becton Dickinson & Co.
Published: 2025-02-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2025-02-12 / Open, Classified

FDA source

Becton Dickinson & Co. began a recall of BD BBL TB Stain Kit K, Catalog (REF): 212522 on 2025-02-12. FDA classified it as Class II and gives the reason as "One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1296-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-12
Posted: 2025-03-06
Recalling firm: Becton Dickinson & Co
Product: BD BBL TB Stain Kit K, Catalog (REF): 212522
Product code: JTS Stains, Microbiologic
Reason for recall: One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of 30Apr2025.
FDA root cause: Under Investigation by firm
Action: On February 12, 2025 URGENT: MEDICAL DEVICE PRODUCT REMOVAL letters were sent to distributors. Please Take the Following Actions: 1. Immediately inspect your inventory for the specific catalog and lot number listed to determine if the lot in your possession are impacted and immediately discard any remaining inventory of the affected product. 2. Ensure the contents of this notification are read and understood. 3. Identify all customers within your distribution network that purchased any affected product as defined in this Product Recall. Provide a copy of the attached customer letter to all customers who received the affected lots to advise them of this Product Recall on BD s behalf. 4. Complete the attached Distributor Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. BD is committed to advancing the world of health. Our primary objectives are patient and user safety and providing you with quality products. We apologize for any inconvenience this issue may have caused you and thank you in advance for helping us to resolve this matter as quickly and effectively as possible. On February 12, 2025 URGENT: MEDICAL DEVICE PRODUCT REMOVAL letters were sent to customers. Actions for Customers: 1) Immediately inspect your inventory for the specific catalog and lot number listed todetermine if the lot in your possession are impacted and immediately discard any remaining inventory of the affected product. 2) Ensure the contents of this notification are read and understood by those within yourorganization. 3) Share and post this customer letter with users of this application at your facility andforward to any customers to whom you may have distributed the product to ensureawareness. 4) Complete the attached Customer Response Form and return to the BD contactnoted on the form whether or not you have any of the impacted material so that BDmay acknowledge
Quantity in commerce: 247 units
Distribution: Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.
Product codes and lots: Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1296-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1296-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-12	2025-03-06

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)