BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx As
FDA device recall Z-1816-2015 · posted 2015-06-18 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Co.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OOI
- Quantity affected
- 7 Viper LT Systems
- Distribution
- Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
- Date initiated
- 2014-11-07
- Date posted
- 2015-06-18
- Date terminated
- 2016-05-09
- Location
- Sparks, MD
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD VIPER LT SYSTEM (K140447) | Becton, Dickinson and Company | 2014-05-20 |