BD MAX PCR Cartridges Catalog #437519, box of 24 cartridges… recallZ-0976-2013 · Becton Dickinson & Co. · initiated Dec 11, 2012
Class II Terminated All recalls posted in March 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0976-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 11, 2012
- Posted by the FDA
- Mar 22, 2013
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 27 boxes/648 cartridges
- Product code
- NJR
- FDA submissions
- K111860
- Distribution
- Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium
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.
Code information (models, lots, serial numbers)
Lot/Exp. date: 2235001 2014-08-22
Other devices under the same FDA submission
2 devices cleared under K111860 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD PCR Cartridge 437519Becton, Dickinson And Company · real time Nucleic acid amplification system1 recall140 reports
- BD MAX™ GBS 441772Becton, Dickinson And Company · Nucleic acid amplification assay system, group b streptococcus, direct specimen test38 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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