FDA Medical Device Recalls (openFDA)
Lexamed: BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.
- Recall number
- Z-1043-2009
- Recalling firm
- Lexamed
- Product
- BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose.
- Status
- Terminated
- Initiated
- 2009-01-13
- Posted
- 2009-03-31
- Terminated
- 2009-12-09
- Reason
- Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
- Root cause
- Process control
- Action
- The recalling firm contacted the customer and notified them of this recall via telephone on 1/13/2009, followed by an Urgent Product Recall Notice which was sent to the customer via Certified mail on 1/14/2009. The letter stated the problem with the affected lot and asked that the customer examine their inventory, remove the affected lot, and return the used and unused vial to LexaMed. The customer is to complete and return the enclosed acknowledgement card by mail or fax. Questions should be directed towards Anne Schuler, QA Manager at 419-693-5307 or by e-mail aschuler@lexamed.net.
- Quantity
- 1 vial
- Distribution
- USA: Utah
- Lot, serial or model codes
- Lot #121208, Expiration Date: 2-12-09.
- 510(k) numbers
- ["K842579"]
- PMA numbers
- not on file
- Product code
- LRF
- Firm FEI
- 1525897
- Firm city
- Toledo
- Firm state
- OH
- 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