Z-0787-06

Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The...

Name: Z-0787-06 Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The...
Creator: Biological and Environmental Control Laboratories Inc
Published: 2006-03-29
License: https://open.fda.gov/license/

Biological & Environmental Control Laboratories / initiated 2006-03-29 / Terminated

FDA source

Biological and Environmental Control Laboratories Inc began a recall of Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek... on 2006-03-29. The reason FDA records is "Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0787-06
Status: Terminated
Initiated: 2006-03-29
Posted: 2006-04-20
Terminated: 2012-03-01
Recalling firm: Biological & Environmental Control Laboratories
Product: Aspergillus Niger Microbial Suspension, Model Numbers: 16404-100 (100 dose) and 16404-20 (20 dose). The product labeling reads as follows: ''b.e.c. Growth-Chek Microbial Suspensions/Aspergillus niger Derived from ATCC Culture #16404**** Store Under Refrigeration***10mL *Shake Well''. The product is distributed by and/or manufactured by BEC Laboratories, Inc., 705 Front Street, Toledo, OH 43605.
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed.
FDA root cause: Other
Action: BEC Laboratories, Inc. sent an ''URGENT PRODUCT RECALL NOTICE'' to their direct account customers via fax transmission on 3/29/2006. The letter informs the customers of the adulteration of the product with yeast and notifies the customers that new suspensions of aspergillus niger will be arriving shortly. The recall letter asks that the customers 1) Destroy the defective lots of product immediately after receiving their shipment of replacement product and that they; 2) Notify their subaccounts of the firm''s recall and ask the subaccount customers to destroy any of the recalled product in their possession. In addition, the recall notice also asks that the direct account customers complete an enclosed ''Product Recall Veriftcation form'', and return it to the recalling firm. This form asks the customers: 1) How many vials from each suspect lot of product have been received? 2)How many vials have been destroyed? 3) in what manner were they destroyed; 4) How many vials have been further distributed to subaccounts; and 5) The name & location of the subaccounts. The Product Recall Verification Form also asks: whether or not the replacement vials of product have been received; and the date on which they were received, and it asks for a signature from the individual who completed the form.
Quantity in commerce: 10 vials of 100 dose and 3 vials of 20 dose.
Distribution: The recalled product was distributed to direct account/customers located in CA, CO, GA, IL, NE, OH , PR and TX.
Product codes and lots: AN1 (100 dose) Lot #022206 - 16404-100, Exp. Date: August 22, 2006, and AN5 (20 dose) Lot #022206 - 16404-20, Exp. Date: August 22, 2006.

Product code JTR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)