Roche Diagnostics Operations, Inc. 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) Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.

Recommended Action

Per FDA guidance

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.