BD MAX System Software Version 4.44A Recalled for Potential Incorrect Results
BD Life Sciences is recalling BD MAX System software version 4.44A due to a defect that may cause incorrect result reporting for specific user-defined protocol assays.
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: The recall involves a medical device software defect that can lead to incorrect diagnostic results, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
BD Life Sciences is recalling software version 4.44A utilized on the BD MAX System. The recall is due to a software anomaly that has the potential to affect some Open System Reagent (OSR) customers utilizing User Defined Protocol (UDP) assays. Customers utilizing only IVD assays are not affected.
The anomaly may cause the OSR customer system to incorrectly switch the columns of the truth table on the user's display. If a user attempts to fix the display data, the display may appear correct, but the database may become incorrect, potentially resulting in incorrect results reporting. The issue is limited to instruments with software version 4.44A installed and only affects customers creating a new UDP with Result Logic or modifying the Result Logic of an existing UDP.
There are 29 US customers and 5 ex-US regions with a BD MAX System running software version 4.44A. Distribution includes the US states of CA, CO, FL, IL, MN, MO, MT, NE, NJ, NY, OH, OR, PA, TX, TN, WA, and WI, as well as Canada, Hong Kong, Taiwan, Turkey, and Europe. Federal Government Agency sales/distribution centers and foreign countries, including VA Fort Harrison and VAMC Austin, are also included in the distribution pattern.
The recalled product
- Product
- Software version 4.44A utilized on the BD MAX System
- Manufacturer
- BD LIFE SCIENCES
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)
- Catalog number 441916
Distribution
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