CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
BD Viper LT recalled by Bd Diagnostic
Bd Diagnostic is recalling BD Viper LT. The recall was initiated on 14 Dec 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1866-2017
- FDA event ID
- 76895
- Recalling firm
- Bd Diagnostic, Sparks, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Dec 2015
- FDA classified
- 19 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Medical Software
Timeline
| 14 Dec 2015 | Recall initiated by company | |
| 19 Apr 2017 | Classified by FDA | +492 days |
| 26 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
BD Viper LT software, version 3.00H
Where it was distributed
2 US customers, 0 Ex-US regions, and 0 distributors 0.
Questions about this recall
Is BD Viper LT recalled?
Yes. Bd Diagnostic recalled BD Viper LT on 14 Dec 2015. The recall is Class II and its status is Terminated. Recall number Z-1866-2017.
Why was it recalled?
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.
Which lots are affected?
Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
Where was it sold?
2 US customers, 0 Ex-US regions, and 0 distributors 0.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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