BD BBL TB Stain Kit Expiration Date Labeling Discrepancy
BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device with labeling discrepancy. Source does not report any actual harm, contamination, or functional defect—only confusion between printed and documented expiration dates. This qualifies as a minor labeling error.
Plain-English summary
Becton Dickinson & Co. (BD) is recalling the BD BBL TB Stain Kit K, Catalog Reference 212522, due to a labeling discrepancy. One component of the kit was shipped with an expiration date of 30 September 2024 printed on it, while the Certificate of Analysis (COA) for that component indicates an expiration date of 30 April 2025.
The recall affects 247 units with Lot Number 4191205 (manufactured 10 July 2024). The kits were distributed domestically in 14 states (Arizona, California, Colorado, Georgia, Kentucky, Illinois, Indiana, North Carolina, New Jersey, New York, Massachusetts, Maryland, Texas, and Washington) and internationally in six countries (Singapore, New Zealand, Chile, Australia, Taiwan, and Malaysia).
The discrepancy between the printed expiration date and the COA creates uncertainty about the correct product validity period. Affected users should contact Becton Dickinson & Co. or their distributor to determine the correct expiration date for affected kits. Do not rely solely on the printed expiration date without consulting the Certificate of Analysis or official guidance from the manufacturer.
The recalled product
- Product
- BD BBL TB Stain Kit K, Catalog (REF): 212522
- Manufacturer
- Becton Dickinson & Co.
- Category
- Medical Device — TB Stain Kit
- Hazard
- Affected units
- 247
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Catalog (REF): 212522
- UDI-DI: 00382902125228
- Expiration Date: 2025/04/30
- Date of Manufacture: 07/10/2024
- Lot Number: 4191205
Distribution
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