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.
This recall has been terminated (originally issued May 3, 2013).
- Recall Initiated
- February 8, 2013
- Posted
- May 3, 2013
- Terminated
- May 13, 2013
- Recall Number
- Z-1215-2013
- Quantity
- 77 kits
- Firm Location
- Sparks, MD
- Official Source
- View on FDA website ↗
Reason for Recall
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
Distribution
Distributed in the states of CA, FL, GA, NJ, and TX.
Lot / Code Info
Lot No./Exp. Date: 2237214 / 2013-10-31.
Root Cause
Environmental control
Action Taken
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 RegulatoryComplianceFax@BD.com. If further assistance is needed regarding replacements, please contact BD Customer Service Department at 1-800-675-0908.