Recall archive / FDA device enforcement
IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832 — FDA record Z-0362-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM in serum and plasma Catalog Number: IA3832
- Reason
- 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 instruments testing order. Can lead to an elevation in Quality Control and Patient results of up to +13% for lgA and +51% for lgM respectively, which may lead to a delay in running patient samples or erroneous elevated test results
- Classification
- Class II
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 20 kits US in total
- Agency-reported status
- Terminated
- Source record identifier
- Z-0362-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | GTIN: 05055273203882 All lots |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide Distribution: CA, NC, NJ and WV,
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Dec 14, 2022
- Recall initiation date
- Nov 1, 2022
- Center classification date
- Dec 2, 2022
- Termination date
- Jun 18, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.