Class 2 Device Recall Tinaquant DDimer

• Date Initiated by Firm: October 03, 2023
• Date Posted: November 20, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0352-2024
• Recall Event ID: 93282
• 510(K)Number: K062203
• Product Classification: Fibrin split products - Product Code GHH
• Product: Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
• Code Information: All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)
• FEI Number: 1823260
• Recalling Firm/ Manufacturer: Roche Diagnostics Operations, Inc.; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Roche Support Network Customer Support Center; 800-428-2336
• Manufacturer Reason for Recall: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT MEDICAL DEVICE CORRECTION notification letter dated 10/3/23 was sent to customers. Actions Required " Roche recommends using citrated plasma for D-Dimer quantification until further notice. " If your laboratory continues to use Li-heparin plasma for D-Dimer quantification, you are required to confirm all results between 0.5 g FEU/mL and 0.675 g FEU/mL with another D-Dimer method or with a citrated plasma sample. " If your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testing from Roche. Contact your Roche sales representative to request reimbursement. " Please complete all sections of the Recall Response Form (TP-01981) enclosed with this UMDC and fax it to 1-844-491-7776 or email it to roche5037@sedgwick.com. " File this Urgent Medical Device Correction (UMDC) for future reference. Credit for Confirmatory Testing If your laboratory continues to use Li-heparin plasma for D-Dimer quantification and chooses to confirm results with another method, you may request credit for that testing from Roche. Contact your Roche sales representative to request reimbursement. Distributor Actions Required " Read the enclosed Customer UMDC TP-01986. " Within 14 days from receipt of this UMDC, distribute a copy of the enclosed Customer UMDC TP-01986 to all customers to whom you have shipped the Tina-quant D-Dimer assays listed above in the last 2 years. " Please complete all sections of the Distributor Recall Response Form (TP-01985) enclosed with this UMDC and fax it to 1-844-491-7776 or email it to roche5037@sedgwick.com. " File this UMDC and the enclosed Customer UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.
• Quantity in Commerce: 5,263 kits
• Distribution: US Nationwide distribution.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

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