Device Recall BD Viper LT System 의 리콜

Recall

70164

Class 2

Z-1816-2015

2014-11-07

2015-06-18

Terminated

United States

2016-05-09

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132379

Potential for false positive chlamydia trachomatis (ct) results and neisseria gonorrhoeae (gc) results when processing the ct qx and gc qx assays on the bd viper lt instrument.

BD sent an Urgent Field Corrective Action letter dated November 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were advised: a. Include the date recall was initiated, if it is already underway or the date your firm plans to start the recalling process. b. How do you plan to notify all the consignees affected by this recall? (press release, letter, telefax, telephone, e-mail, visit, etc.) The customer was initially contacted via a phone call and subsequently provided with a written communication. c. How do you plan to monitor the number of consignees non-responding to the recall communication? The single US customer was contacted by phone and provided the written communication. d. How do you plan to do effectiveness checks of this recall? The affected instrument will be corrected. e. Date your firm ceased further distribution of the product(s). Product was not placed on hold. This issue does not affect new customers. f. How do you plan to store the recall product? BD has not requested that instruments or reagents be returned. g. How do you plan to dispose of the recall products? BD is not requesting that customers return the instruments or reagents. If you require further assistance or clarification, please contact the BD Technical Services Department at 1-800 638-8663.