Z-1043-2009

BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions...

Name: Z-1043-2009 BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions...
Creator: Lexamed
Published: 2009-01-13
License: https://open.fda.gov/license/

Biological & Environmental Control Laboratories / initiated 2009-01-13 / Terminated / root cause: manufacturing process

FDA source

Lexamed began a recall of BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and... on 2009-01-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1043-2009
Status: Terminated
Initiated: 2009-01-13
Posted: 2009-03-31
Terminated: 2009-12-09
Recalling firm: Biological & Environmental Control Laboratories
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.
Product code: LRF Candida Spp., Direct Antigen, Id
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 1 vial
Distribution: USA: Utah
Product codes and lots: Lot #121208, Expiration Date: 2-12-09.

Product code LRF

K842579Class IB.e.c. Growth Chek Microbial SuspensionsBiological & Environmental Control Laboratories / cleared 1984-07-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)