Recall archive / FDA device enforcement
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215 — FDA record Z-2609-2023
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 Aug 3, 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
- Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- Reason
- there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
- Classification
- Class II
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 66 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2609-2023
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 | UDI-DI: 05055273208986; Lot Number: 1308UE |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US States: GA, OH, OR, PA, TX, VA
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
- Sep 27, 2023
- Recall initiation date
- Aug 3, 2023
- Center classification date
- Sep 19, 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.