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BD BBL TB Stain Kit K, Catalog (REF): 212522 recallZ-1296-2025 · Becton Dickinson & Co. · initiated Feb 12, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1296-2025
Status
Open, Classified
Initiated by the company
Feb 12, 2025
Posted by the FDA
Mar 6, 2025
Recalling firm
Becton Dickinson & Co.
Quantity
247 units
Product code
JTS
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 description

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

Code information (models, lots, serial numbers)

Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page