FDA Medical Device Recalls (openFDA)
Integrated Science Systems Inc: Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
- Recall number
- Z-1911-2016
- Recalling firm
- Integrated Science Systems Inc
- Product
- Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
- Status
- Terminated
- Initiated
- 2016-02-19
- Posted
- 2016-06-03
- Terminated
- 2017-02-28
- Reason
- Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
- Root cause
- Process control
- Action
- Integrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.
- Quantity
- 2625 kits
- Distribution
- Nationwide distribution to CA only.
- Lot, serial or model codes
- Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LHJ
- Firm FEI
- 3011450093
- Firm city
- Augusta
- Firm state
- GA
- 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