Home › RANDOX LABORATORIES LIMITED › IgA
IgA
RANDOX LABORATORIES LIMITED · Model IA3895 · UDI-DI 05055273203899
CZP
Prescription
1
510(k) clearances
11
Adverse events
3
Recalls
21
Facilities
Description
The product is intended for the quantitative in vitro determination of IgA in serum or plasma.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.