—#212412

Product

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

FDA product code: JTS — Stains, Microbiologic
Device class: Class 1
Medical specialty: Hematology
Affected lot / code info: Catalog (REF): 212522; UDI-DI: 00382902125228; Expiration Date: 2025/04/30; Date of Manufacture: 07/10/2024; Lot Number: 4191205;

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Becton Dickinson & Co.
Address: 7 Loveton Cir, Sparks, Maryland 21152-9212

Distribution

Distribution pattern: Domestic: AZ, CA, CO, GA, KY, IL, IN, NC, NJ, NY, MA, MD, TX, WA. International: Singapore, New Zealand, Chile, Australia, Taiwan, Malaysia.

Timeline

Recall initiated: 2025-02-12
Posted by FDA: 2025-03-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212412. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.