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.
Reported: April 3, 2013 Initiated: December 11, 2012 #Z-0976-2013
Product Description
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.
Reason for Recall
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Details
- Recalling Firm
- Becton Dickinson & Co.
- Units Affected
- 27 boxes/648 cartridges
- Distribution
- Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
- Location
- Sparks, MD
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Becton Dickinson & Co.. Units affected: 27 boxes/648 cartridges.
Why was this product recalled? ▼
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 3, 2013. Severity: Moderate. Recall number: Z-0976-2013.
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