Recall Z-0976-2013— Becton Dickinson & Co.

Name: FDA recall Z-0976-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-11

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2012-12-11, terminated 2013-07-22. It names one FDA 510(k) clearance: K111860. Product: 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: Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2012-12-11
Terminated: 2013-07-22
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K111860 — BD MAX GBS ASSAY, BD MAX INSTRUMENTBecton, Dickinson & CO·cleared 2012-02-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.