FDA Medical Device Recalls (openFDA)
Bd Diagnostic: BD Viper LT software, version 3.00H
- Recall number
- Z-1866-2017
- Recalling firm
- Bd Diagnostic
- Product
- BD Viper LT software, version 3.00H
- Status
- Terminated
- Initiated
- 2015-12-14
- Posted
- 2017-04-04
- Terminated
- 2017-04-19
- 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.
- 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
- 2
- Distribution
- 2 US customers, 0 Ex-US regions, and 0 distributors 0.
- Lot, serial or model codes
- Catalog Number 443157 443153 443155 443156 442947 443902 Version Number 3.00H 3.00H
- 510(k) numbers
- ["K140447"]
- PMA numbers
- not on file
- Product code
- OOI
- Firm FEI
- 1119779
- Firm city
- Sparks
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28