Z-1816-2015Class II

BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis...

Name: Z-1816-2015 BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis...
Creator: Becton Dickinson & Co.
Published: 2014-11-07
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2014-11-07 / Terminated / root cause: design

FDA source

Becton Dickinson & Co. began a recall of BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec... on 2014-11-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1816-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-07
Posted: 2015-06-18
Terminated: 2016-05-09
Recalling firm: Becton Dickinson & Co
Product: BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
Product code: OOI Real Time Nucleic Acid Amplification System
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 7 Viper LT Systems
Distribution: Worldwide distribution to US (state of LA), Hong Kong, Austria, China, France, and the UK.
Product codes and lots: Only the BD Viper LT Systems, catalog number 442839, that utilize the CT/GC Assays are affected. Serial numbers VLT0040, VLT0001, VLT0015, VLT0016, VLT0023, VLT0026, VLT0033.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1816-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1816-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-18

Product code OOI

K140447Class IIBd Viper Lt SystemBecton, Dickinson and Company / cleared 2014-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)