Reported Apr 3, 2013 · Terminated
BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences…
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. · BD Diagnostic Systems · Sparks, MD · 21152-0999
Is this the product you have?
- BD MAX PCR Cartridges Catalog #437519
- box of 24 cartridges labeled in part***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5***BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System
- Lot codes and dates
- Lot/Exp
- date2235001 2014-08-22
- Amount recalled
- 27 boxes/648 cartridges
Where it was sold
Why it was recalled
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
This product could cause temporary or reversible health problems — stop using it.
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