BD COR system software issue could produce possible false negative results
BD COR System Software version 8.80 and above is being recalled because of a potential functionality issue supporting the Over labeling feature that could lead to possible false negative results. 7 systems affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Risk-of-harm product: the manufacturer states the issue could lead to false negative results, with no patient harm reported in the source.
Plain-English summary
BD COR System Software, model number 444829, UDI-DI 00382904448295, software version 8.80 and above, is being recalled. The action covers 7 systems.
The stated reason is the potential for a functionality issue that supports the Over labeling feature and could lead to possible false negative results. The FDA classified the action as Class II. The source does not report any patient harm having occurred.
Distribution was worldwide, including nationwide in the United States in Florida, Texas and Michigan.
Laboratories should identify affected systems using the model number, UDI-DI and software version above and follow the instructions issued by BD.
The recalled product
- Product
- BD COR System Software. Model Number: 444829.
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 7
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 (1)
- Model Number: 444829. UDI-DI: 00382904448295. Software version 8.80 and above.
Distribution
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