Randox Laboratories Ltd. is recalling 108 kits of Calibration Serum Level 3 (Catalog Number CAL2351), an essential component used to calibrate clinical chemistry tests. The target value for Alkaline Phosphatase (ALP) for the AMP method was miscalculated by approximately 10% for RX Series laboratory instruments. This defect can lead to inaccurate test results for both quality control checks and patient samples. Because this product is used in medical diagnostic settings, you should contact your healthcare provider or the manufacturer for further instructions regarding affected results.
The 10% mis-assignment of the Alkaline Phosphatase target value can cause medical laboratory equipment to produce incorrectly low or high results for patients. Inaccurate ALP readings may lead to the misdiagnosis or delayed treatment of liver, gallbladder, or bone disorders.
manufacturer or healthcare provider 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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