Randox Laboratories is recalling 66 kits of Liquid Assayed Chemistry Control Premium Plus Level 3 because of a transcription error in the Instructions for Use (IFU). The printed values for Caeruloplasmin (a protein that carries copper in the blood) are incorrect on the instructional sheet, although the actual target and range values for the product remain accurate. While most clinical laboratories use the correct target values in practice, this error could potentially lead to the misreporting of patient lab results if a technician relies on the incorrect printed sheet.
The incorrect values printed for Caeruloplasmin on the instruction sheet may cause laboratory equipment to be calibrated incorrectly or results to be misinterpreted. This error could lead to inaccurate patient medical reports, which might affect subsequent diagnosis or treatment decisions.
Instruction Correction and Consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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