BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA… recallZ-1215-2013 · Becton Dickinson & Co. · initiated Feb 8, 2013
Class II Terminated All recalls posted in May 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
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
FDA root cause category: Environmental control
What the company is doing
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.
Recall details
- Recall number
- Z-1215-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 8, 2013
- Posted by the FDA
- May 3, 2013
- Recalling firm
- Becton Dickinson & Co.
- Quantity
- 77 kits
- Product code
- JTY
- FDA submissions
- K081825, K090827, K090971, K091730
- Distribution
- Distributed in the states of CA, FL, GA, NJ, and TX.
Product description
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.
Code information (models, lots, serial numbers)
Lot No./Exp. Date: 2237214 / 2013-10-31.
Other devices under the same FDA submission
4 devices cleared under K081825, K090827, K090971, K091730 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Control Set for the BD ProbeTec™ (CT/GC) 441125Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA2 reports
- BD ProbeTec™ (GC) Qx Amplified DNA Assay 441124Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA1 report
- BD Viper™ Extraction Reagent and Lysis Trough 441128Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA1 report
- BD FOX™ Extraction Tubes 441129Becton, Dickinson And Company · DNA-REAGENTS, NEISSERIA1 report
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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