Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall see related information
Date Initiated by Firm March 29, 2006
Date Posted April 20, 2006
Recall Status1 Terminated 3 on March 01, 2012
Recall Number Z-0787-06
Recall Event ID 35178
Product Classification Kit, Quality Control For Culture Media - Product Code JTR
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.
Code Information 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.
Recalling Firm/
Manufacturer		 Biological and Environmental Control Laboratories Inc
705 Front St
Toledo OH 43605-2107
For Additional Information Contact
419-693-5307
Manufacturer Reason
for Recall		 Aspergillus niger microbial suspension, found to be contaminated with yeast, was distributed.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-