BD Max Instrument Reader Spare Part Recalled for False Positive Results
Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.
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 is classified as FDA Class II and involves a confirmed trend of false positive diagnostic results, which poses a risk of incorrect clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Becton Dickinson & Co. is recalling 23 units of the BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409. The affected units are repaired reader spare parts used in the BD MAX System, which is designed for automated extraction, purification, amplification, and detection of nucleic acids in clinical, industrial, and research settings.
The recall is being issued because a trend for false positive Candida glabrata results has been confirmed. These discrepant results impact the Candida glabrata target only when in the presence of a Trichomonas vaginalis true positive. The agency has classified this recall as Class II.
The affected units were distributed worldwide, including nationwide in the United States and in several countries in Europe and the Middle East. Specific serial numbers are listed in the recall documentation. Users of the BD MAX System should check their equipment against the provided serial numbers and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - 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 f
- Manufacturer
- Becton Dickinson & Co.
- Affected units
- 23
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 (20)
- Serial Numbers: 079577 to 079896
- 78154
- 78503
- 78363
- 78321
- 78584
- 78840
- 78975
- 78711
- 77048
- 79783
- 78857
- 79162
- 78387
- 78182
- 78832
- 78905
- 77062
- 78856
- 78352
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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