Reported Sep 27, 2023 · Ongoing
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Randox Laboratories Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North) · N/A
Is this the product you have?
- Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- Lot codes and dates
- UDI-DI05055273208986
- Lot Number1308UE
- Amount recalled
- 66 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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