BD FMC7 FITC Recalled for Incorrect Expiration Date Labeling
Becton, Dickinson and Company is recalling 78 units of BD FMC7 FITC reagent because the vial labels display an incorrect expiration date.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a labeling error regarding the expiration date, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) product has an incorrect expiration date listed on the vial label. The affected product is the BD FMC7 FITC, Model 430918, which is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
The recall involves 78 units of the product. The distribution pattern includes worldwide distribution, specifically US nationwide in the states of TX, NY, GA, NJ, AL, MA, IL, PA, DC, FL, CA, MD, OK, and the country of Taiwan. The specific lot number is 5341918. The label incorrectly lists the expiry date as 03/31/2017, whereas the correct expiry date is 6/30/16.
Consumers and healthcare facilities should check their inventory for this specific model and lot number. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.
The recalled product
- Product
- BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen.
- Manufacturer
- Becton, Dickinson and Company, BD Biosciences
- Hazard
- Affected units
- 78
Distribution
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