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

FDA device recall Z-1215-2013 · posted 2013-05-03 · Terminated

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.

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.

Root cause

Environmental control

Status

Terminated

Product code

JTY

Quantity affected

77 kits

Distribution

Distributed in the states of CA, FL, GA, NJ, and TX.

Date initiated

2013-02-08

Date posted

2013-05-03

Date terminated

2013-05-13

Location

Sparks, MD

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