FDA Medical Device Recalls (openFDA)
Thermo Biostar, Incorporated: Chlamydia OIA. For in vitro diagnostic use
- Recall number
- Z-0615-03
- Recalling firm
- Thermo Biostar, Incorporated
- Product
- Chlamydia OIA. For in vitro diagnostic use,
- Status
- Terminated
- Initiated
- 2003-02-07
- Posted
- 2003-03-06
- Terminated
- 2003-05-02
- Reason
- Chlamydia IVD test kits may contain diluted conjugate reagent. Use may produce a false negative result with a low positive patient sample.
- Root cause
- Other
- Action
- All consignees were notified by telephone on 2/6/2003, followed by letter on 2/10/2003.
- Quantity
- 286 units
- Distribution
- Nationwide, and to France, New Zealand and Spain.
- Lot, serial or model codes
- Catalog No. CHL30, Lot No. 132117, 132117A,133101
- 510(k) numbers
- ["K951010"]
- PMA numbers
- not on file
- Product code
- LJC
- Firm FEI
- 1720655
- Firm city
- Louisville
- Firm state
- CO
- 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