Becton Dickinson Recalls BBL Crystal Enteric/Nonfermenter ID Kits
Becton Dickinson is recalling BBL Crystal Enteric/Nonfermenter ID Kits because reversed reagent positions may cause bacteria misidentification.
What this means for you
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: The recall is classified as FDA Class II, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a diagnostic error (misidentification) rather than a direct physical injury or contamination, fitting the Moderate category for a voluntary precautionary recall of a medical device.
Plain-English summary
Becton Dickinson & Co. is recalling BBL Crystal Enteric/Nonfermenter ID Kits, Catalog # 24500. These in-vitro diagnostic reagents are used for microbiological testing to identify aerobic gram-negative bacteria. The recall involves 67,820 units distributed worldwide, including in the United States and various international locations.
The recall was initiated because the reagents in the test kit may be reversed in well positions. When utilized in this condition, the kits may lead to the misidentification of bacteria. This defect affects the accuracy of the diagnostic results.
Healthcare facilities and laboratories that have received these kits should stop using them and contact Becton Dickinson for instructions on how to return or dispose of the product. The affected lots have expiration dates ranging from February 20, 2013, to March 27, 2013.
The recalled product
- Product
- Becton, Dickinson and Company, BBL Crystal Enteric/Nonfermenter ID Kit, Catalog # 24500, cartons of 20 kits, In-vitro diagnostic reagents for microbiological testing. The BBL Crystal Enteric/Nonfermentor (E/NF) identification (ID) System is for the identification of aerobic gram
- Manufacturer
- Becton Dickinson & Co.
- Hazard
- Affected units
- 67,820
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 (9)
- Lot Number/ Exp Date 2086315 February 20
- 2013 2101435 February 20
- 2013 2104316 February 27
- 2013 2129460 February 27
- 2013 2129487 March 13
- 2013 2163211 February 27
- 2013 2163213 March 20
- 2013 2163215 March 27
- 2013
Distribution
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