DAQClass I

Igg (fd Fragment Specific), Antigen, Antiserum, Control

Immunology · 21 CFR 866.5540

MDR events1All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances1All time

Recent MDR events

1 adverse event reports on file

EARLYVUE VS30 VITALS MONITORDec 15, 2025
MalfunctionPhilips Medizin Systeme Böblingen Gmbh9610816-2025-001226

Event type breakdown

Malfunction1

Most-reported manufacturers

Philips Medizin Systeme Böblingen Gmbh1

Recalls

1 recall events for this product code

Roche Diagnostics Corporation
TerminatedApr 13, 2019
Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190
New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. ***Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays***
Z-1147-2019 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

1 clearances for this product code

Helena LaboratoriesMar 22, 1989
K891299 · MID-LEVEL IGG KIT CAT. NO. 9315