Recall archive / FDA device enforcement
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and ... — FDA record Z-2021-2023
Reported ongoing
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 May 4, 2023. 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
- Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
- Reason
- Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
- Classification
- Class III
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 kit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2021-2023
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:05055273203868 Batch/Lot Number: 2031EC Exp. Date: 28th Nov 23 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
CA, IL, VA, WA, WI including PR
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 5, 2023
- Recall initiation date
- May 4, 2023
- Center classification date
- Jun 28, 2023
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.