Recall Z-0787-06 ยท JTR Kit, Quality Control For Culture Media
Biological and Environmental Control Laboratories Inc
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 4360
| Date | Apr 20, 2006 (initiated Mar 29, 2006) |
| Status | Terminated |
| Reason | Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed. |
| 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 the |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.