Class 3 Device Recall ELaCL AntiCardiolipin ELISA Kit

• Date Initiated by Firm: January 11, 2006
• Date Posted: May 04, 2006
• Recall Status: Terminated on May 03, 2006
• Recall Number: Z-0835-06
• Recall Event ID: 34945
• 510(K)Number: K060176
• Product Classification: System, Test, Anticardiolipin Immunological - Product Code MID
• Product: EL-aCL Anti-Cardiolipin ELISA Kit; an in-vitro diagnostic anticardiolipin immunological test system; 192 tests per kit; catalog #201-204; Thera Test Laboratories Inc., 1111 North Main Street, Lombard, IL 60148
• Code Information: catalog #201-204: kit lot 09055514, exp. 14-JUL-2006, serum diluent lot 09055546, exp 04-OCT-2006; and kit lot 12055603, exp. 09-NOV-2006, serum diluent lot 11055595, exp. 18-NOV-2007
• FEI Number: 1421346
• Recalling Firm/ Manufacturer: Thera Test Laboratories, Inc.; 1111 N Main St; Lombard IL 60148-1360
• For Additional Information Contact: Dr. Marius C. Teodorescu; 800-441-0771
• Manufacturer Reason for Recall: The specimen diluent contained in the kits was contaminated with a fungal growth. Also, a portion of kit lot 09055514 was shipped without the Data Sheet, part #201-204.
• FDA Determined Cause: Other
• Action: On 10/26/05, Thera Test telephoned the 3 accounts who received lot 09055514 without the Data Sheet in the kits, and sent them copies of the Data Sheet for insertion into the 6 kits on hand at the consignees. Between 1/4-9/06, Thera Test telephoned the 17 accounts receiving kit lots 09055514 and 12055603, and sent them follow-up letters dated 1/9/06 with replacement bottles of Specimen Diluent. The accounts were advised of the fungal contamination found in some bottles of the diluent shipped with the kit lots, and were requested to destroy any remaining bottles of the Specimen Diluent in their kits and replace them with the bottles of diluent sent with the letter.
• Quantity in Commerce: 53 kits
• Distribution: California, Connecticut, Maryland, Pennsylvania, Ohio, New Jersey and Florida.
• 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.

• 510(K) Database: 510(K)s with Product Code = MID