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Igm, Antigen, Antiserum, Control

FDA product code DFT · Class 2 · Immunology

9
Registered devices
1
Adverse events
4
Recalls
33
510(k) clearances

Devices with this code

Alinity — Abbott GmbHARCHITECT — Abbott GmbHIgM — RANDOX LABORATORIES LIMITEDARCHITECT — ABBOTT LABORATORIESImmunoFix Controls — HELENA LABORATORIES CORPORATIONAlinity — ABBOTT IRELANDYumizen C1200 Immunoglobulin M — HORIBA ABX SASARCHITECT — ABBOTT IRELANDIgM — RANDOX LABORATORIES LIMITED

Recent recalls

DateFirmReason
2022-11-01Randox 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
2018-05-16Abbott Laboratories, IncAn update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the variou
2005-11-10Abbott Laboratories Diagnostic DivThese specific protein assays are not meeting the 57-day on board stability claim
2002-07-31Abbott Laboratories Diagnostic DivAssay may produce falsely low IgM results without error codes when testing specimens contain elevated serum paraproteins associated with various myeloma or othe

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.