FDA Medical Device Recalls (openFDA)
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 number
- Z-0352-2024
- Recalling firm
- Roche Diagnostics Operations, Inc.
- 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)
- Status
- Open, Classified
- Initiated
- 2023-10-03
- Posted
- 2023-11-20
- Terminated
- not on file
- Reason
- Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
- Root 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
- 5,263 kits
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)
- 510(k) numbers
- ["K062203"]
- PMA numbers
- not on file
- Product code
- GHH
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28