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Tinaquant IgA Gen2

Roche Diagnostics GmbH · Model 3507343190 · UDI-DI 04015630919680

CZP Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Recalls

Date	Firm	Reason
2022-11-01	Randox Laboratories Ltd.	Update to the carryover avoidance technical bulletin to detail that IgA and IgM assays should not be run immediately after Fructosamine Catalogue Number FR3133 or FR4030 on the RX
2019-06-03	Roche Diagnostics Corporation	Calibration failures with Std.E, Sens.E, or Dup.E error due to atypical reaction kinetics and quality control failures have occurred due to contamination of R1 reagent with R3 reag
2018-05-16	Abbott Laboratories, Inc	An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.