Z-0976-2013Class II

BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm...

Name: Z-0976-2013 BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm...
Creator: Becton Dickinson & Co.
Published: 2012-12-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2012-12-11 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:***BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du... on 2012-12-11. FDA classified it as Class II and gives the reason as "Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0976-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-11
Posted: 2013-03-22
Terminated: 2013-07-22
Recalling firm: Becton Dickinson & Co
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.
Product code: NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Reason for recall: Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: BD Diagnostic Systems issued an Urgent Product Recall letter via UPS delivery on December 11, 2012. The letter identified the product, the problems, and the action to be taken by the customer. Customers were instructed to take the following actions: Discontinue and discard any affected product. BD would send replacements for the discarded material. Complete the attached form whether or not they have any inventory remaining so that the firm may acknowledge their receipt of the notification. Fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 or Email to [email protected].. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908. For all other inquiries, contact BD Technical Services Department at 1-800-638-8663. The BD site in Belgium was notified via email. For questions regarding this recall call 410-316-4054.
Quantity in commerce: 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
Product codes and lots: Lot/Exp. date: 2235001 2014-08-22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0976-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0976-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-22

Product code NJR

K111860Class IBd Max Gbs Assay, Bd Max InstrumentBecton, Dickinson & CO / cleared 2012-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)