Class 3 Device Recall Tosoh Folate calibrator sets

• Date Initiated by Firm: September 01, 2006
• Date Posted: October 28, 2006
• Recall Status: Terminated on July 21, 2007
• Recall Number: Z-0082-2007
• Recall Event ID: 36506
• 510(K)Number: K992365
• Product Classification: Folate calibrator sets - Product Code JIS
• Product: TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The calibrators are packaged in 1 ml glass vials with 12 glass vials per box.
• Code Information: Lot Code: G431726 (shipped after June 6, 2006)
• Recalling Firm/ Manufacturer: Tosoh Bioscience Inc; 3600 Gantz Road; Grove City OH 43123
• For Additional Information Contact: 614-317-1909
• Manufacturer Reason for Recall: Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument
• FDA Determined Cause: Other
• Action: The firm mailed Urgent: Medical Device Recall letters to their customer accounts on 9/5/2006. The letter informs the customers of the calibration problem and asks that the customers examine their inventories for the presence of the suspect product and place any product found in quarantine. The letter also asks that the customers identify their subaccount/customers and notify them of the recall with a copy of the recall letter, if the product has been further distributed. The recall letter is accompanied by a Response form which the customer is asked to complete and return to TOSOH as soon as possible. The Response form requires reporting of infomation concerning the amount and disposition of all product on-hand. It also includes a section for use by the distributor/customers for indicating whether or not their customers have been notified as well as the names and addressed of the distributor''s subaccounts. Should the customer(s) have any questions, the recall letter provides a telephone number and the name of a contact person to whom questions can be addressed.
• Quantity in Commerce: 151 boxes
• Distribution: Nationwide distribution ---- including states of AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, OR, PA, PR, SC, TX, WA, WI, WV, and WY.
• 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 = JIS and Original Applicant = TOSOH MEDICS, INC.