Z-1215-2013Class II

BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each...

Name: Z-1215-2013 BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each...
Creator: Becton Dickinson & Co.
Published: 2013-02-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2013-02-08 / Terminated / root cause: manufacturing process

FDA source

Becton Dickinson & Co. began a recall of BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria... on 2013-02-08. FDA classified it as Class II and gives the reason as "Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits". 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-1215-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-08
Posted: 2013-05-03
Terminated: 2013-05-13
Recalling firm: Becton Dickinson & Co
Product: BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Product code: JTY Culture Media, For Isolation Of Pathogenic Neisseria
Reason for recall: Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: BD Diagnostic Systems sent an "URGENT PRODUCT RECALL" letter via UPS overnight delivery on February 8, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to verify that these kits have been consumed, returned or destroyed by completing the enclosed form. The firm will issue a no charge replacement for customers' product. Any product remaining in customers' inventory should be discarded or destroyed per their facility procedures. Complete the attached form regardless if any inventory remains, so that the firm may acknowledge customers' receipt of this notification. It is not necessary to contact BD by telephone to receive replacements. Complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258 OR E-mail to [email protected]. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908.
Quantity in commerce: 77 kits
Distribution: Distributed in the states of CA, FL, GA, NJ, and TX.
Product codes and lots: Lot No./Exp. Date: 2237214 / 2013-10-31.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1215-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1215-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-15	2013-05-03

Product code JTY

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)