Z-0976-2013 Class II Terminated
FDA device recall Z-0976-2013 was initiated by Becton Dickinson & Co. on Dec 11, 2012 and is designated Class II. Reason for recall: Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs. The recall status is terminated (terminated Jul 22, 2013). Affected quantity: 27 boxes/648 cartridges.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2013
- Initiation Date
- Dec 11, 2012
- Termination Date
- Jul 22, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 boxes/648 cartridges
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.
Distribution Pattern
Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
Code Information
Lot/Exp. date: 2235001 2014-08-22
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0976-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026