Recall Z-1866-2017— Bd Diagnostic

Name: FDA recall Z-1866-2017
Creator: U.S. Food and Drug Administration
Published: 2015-12-14

Class II · Terminated

Class II FDA medical device recall by Bd Diagnostic, initiated 2015-12-14, terminated 2017-04-19. It names one FDA 510(k) clearance: K140447. Product: BD Viper LT software, version 3.00H. Reason: 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..

Recalling firm: Bd Diagnostic
Classification: Class II
Status: Terminated
Initiated: 2015-12-14
Terminated: 2017-04-19
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K140447 — BD VIPER LT SYSTEMBecton, Dickinson and Company·cleared 2014-05-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Viper LT software, version 3.00H

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.