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Recall Observatory FDA recall evidence

Device product

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

Z-1296-2025

February 12, 2025

Class II

Product summary

Firm
Becton Dickinson & Co.
Event
Event 96244
Status
Ongoing
Classification
Class II
Quantity
247 units
Official record key
device-enforcement:Z-1296-2025

Official wording

Reason: 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.

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.