BD Max Instrument Recall for False Positive Candida Results
Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.
What this means for you
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 with a confirmed defect leading to false positive diagnostic results, which poses a risk of harm through misdiagnosis or unnecessary treatment, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Becton Dickinson & Co. is recalling 49 refurbished BD Max Instruments (Catalog Numbers 441916 and 441927) with serial numbers CTI1201 through CTI1288. The recall is due to a confirmed trend of false positive results for the Candida glabrata target. This discrepancy occurs specifically when a true positive for Trichomonas vaginalis is also present.
The affected instruments were distributed worldwide, including in the United States (specifically in AL, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, NC, NJ, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Puerto Rico) and in several countries in Europe and the Middle East. The BD MAX System is used for automated extraction, purification, amplification, and detection of nucleic acids in clinical, industrial, and research settings.
Users of these instruments should contact Becton Dickinson & Co. for instructions on how to proceed with the recall. The issue impacts only the Candida glabrata target and does not affect other targets on the system.
The recalled product
- Product
- BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 49
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)
- Serial Numbers: CTI1201-CTI1288
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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