Reported Nov 7, 2018 · Terminated
BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product…
Becton Dickinson & Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Becton Dickinson & Co. · 7 Loveton Cir · Sparks, MD · 21152-9212
Is this the product you have?
BD Max Instrument Reader Spare PartCatalog Number 8090369/44336444336409 (Repaired
- Reader spare part) - Product UsageThe 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 BD MAX System is also capable of automated amplification and detection of target nucleic acid sequences for use in clinical, industrial, and research settings
- Lot codes and dates
- Serial Numbers
079577 to 07989678154785037836378321785847884078975787117704879783788577916278387781827883278905770627885678352789037866778665789287898677108775437861578481773737770778927
- Serial Numbers
- Amount recalled
- 23
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
A trend for false positive Candida glabrata results has been confirmed. The discrepant results impact the Candida glabrata target only, when in the presence of a Trichomonas vaginalis true positive.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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