Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31
Summary
The FDA issued a Class II for Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Ma by Roche Diagnostics Operations, Inc.. Reason: Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples..
Details
Source
Device Recall
External ID
Z-0352-2024
Action Date
2023-11-29
Status
Ongoing
Category
device
Product Description
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)
Lot/Code Info: All Lots Affected. UDI: 04015630914593 - (cobas c 311, 501 and 502; INTEGRA 400 plus) UDI: 07613336133651 - (cobas c 303 and 503)
Quantity Affected: 5,263 kits
Reason for Recall
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-03
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Roche Diagnostics Operations, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Roche Diagnostics Operations, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Roche Diagnostics Operations, Inc. have FDA actions?
Roche Diagnostics Operations, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0352-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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