Z-1866-2017Class II

BD Viper LT software, version 3.00H

Name: Z-1866-2017 BD Viper LT software, version 3.00H
Creator: Bd Diagnostic
Published: 2015-12-14
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2015-12-14 / Terminated / root cause: software

FDA source

Bd Diagnostic began a recall of BD Viper LT software, version 3.00H on 2015-12-14. FDA classified it as Class II and gives the reason as "BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1866-2017
Classification: Class II
Status: Terminated
Initiated: 2015-12-14
Posted: 2017-04-04
Terminated: 2017-04-19
Recalling firm: Becton Dickinson & Co
Product: BD Viper LT software, version 3.00H
Product code: OOI Real Time Nucleic Acid Amplification System
Reason for recall: BD has confirmed reports that lower than expected RFU values were generated on customer BD Viper LT Systems after the installation of software version 3.00H. As RFU values decrease, results approach the assay cutoff threshold which has the potential to impact test results.
Root cause tag: software
FDA root cause: Software design
Action: Recall action was initiated on December 14, 2015 when software version 3.00H was removed from the two customer instruments. The 2 affected US customers were contacted via email and were also mailed a letter via UPS overnight express.
Quantity in commerce: 2
Distribution: 2 US customers, 0 Ex-US regions, and 0 distributors 0.
Product codes and lots: Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1866-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1866-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-19

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)