FDA Medical Device Recalls (openFDA)
bioMerieux: VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
- Recall number
- Z-1209-03
- Recalling firm
- bioMerieux
- Product
- VIDAS Chlamydia Assay (CHL) for In-Vitro Diagnostic Use Product Number: 30101
- Status
- Terminated
- Initiated
- 2003-08-06
- Posted
- 2003-10-15
- Terminated
- 2005-05-17
- Reason
- Product's decrease in sensitivity may result in false negative results
- Root cause
- Other
- Action
- On August 6, 2003, Biomerieux''s recall letter and customer response form was sent to all US Customers and Biomerieux Global Customer Service in France, who is responsible for notification to all non-US bioMerieux subsidiaries. Non-US subsidiaries/distributors are responsible for notifying non-US Customers. VIDAS Chlamydia (CHL) Assay (product number 30 101) with Lot numbers 040212-0 and 040218-0 will be destroyed in the field.
- Quantity
- 2204
- Distribution
- Nationwide NY, PA, IL, NJ, MO, NJ, NC, MI, WV, MD, CA, IN, MN, FL, WA, KS, GA, AZ, IA, SD, WI, SC, MT, TX, AK, OK, VA, CO, AL, OH, AR, MA, ND, CT, HI International: Japan, Argentina, Brazil, Chile, China, Columbia, Korea, Mexico, Canada, SA
- Lot, serial or model codes
- Lot Numbers: 040212-0, 040218-0 Expiration date: 2/2004
- 510(k) numbers
- ["K915884"]
- PMA numbers
- not on file
- Product code
- LJC
- Firm FEI
- 3002769706
- Firm city
- Durham
- Firm state
- NC
- 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