Chemistry Quality Control Material Recalled for Transcription Error in Instructions
Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a documentation error with no reported illnesses or injuries. While incorrect standard deviation values could theoretically affect laboratory result interpretation, the source explicitly states the risk is mitigated because the correct target and range values are available and most laboratories rely on these in practice.
Plain-English summary
Randox Laboratories Ltd. recalled 66 kits of Liquid Assayed Chemistry Control Premium Plus Level 3 (Catalog Number LAE4215, Lot Number 1308UE) due to a transcription error in the product's Instructions for Use.
The standard deviation values for Caeruloplasmin testing contained in the printed instructions are incorrect. These incorrect values could potentially lead to misreporting of patient test results if used to evaluate the quality control material's performance.
The product's target and range values, which are the primary values used in clinical practice, are correct. Randox states that the risk is mitigated because most clinical laboratories use the target and range values for result interpretation. The recalled kits were distributed to laboratories in six US states: Georgia, Ohio, Oregon, Pennsylvania, Texas, and Virginia.
The recalled product
- Product
- Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
- Manufacturer
- Randox Laboratories Ltd.
- Hazard
- transcription-error
- misreporting-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 05055273208986
- Lot Number: 1308UE
Distribution
Distributed in 6 states:
- GA
- OH
- OR
- PA
- TX
- VA
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