Randox recalls Calibration Serum Level 3 (CAL2351) due to misassigned Alkaline Phosphatase target causing inaccurate test results. Affected units may have errors in clinical chemistry assays.
Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37¿C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
Randox is recalling Calibration Serum Level 3 (CAL2351) because it has a misassigned Alkaline Phosphatase target that can cause inaccurate test results in clinical chemistry assays. This affects the reliability of patient and quality control samples when used with RX Series instruments.
The serum's Alkaline Phosphatase target is misassigned by about 10% for RX Series instruments. This can lead to inaccurate test results for patient samples and quality control checks in clinical chemistry assays.
Healthcare professionals using the Calibration Serum Level 3 for clinical chemistry assays with RX Series instruments are affected. Patients receiving tests using this serum may have inaccurate results.
Check for the catalog number CAL2351 on the serum label. The lot/batch number is 1214UE with an expiration date of November 28, 2023.
Verify the catalog number CAL2351 and lot/batch number 1214UE on the serum label.
The recall indicates potential inaccuracies in test results, but the serum itself is not unsafe. Users should check the recall details before use.
The recall record does not specify a remedy, so users should check the product details and contact Randox for further guidance.
Inaccurate test results could occur if the serum is used with RX Series instruments, potentially affecting patient samples and quality control checks.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0753-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-0753-2024 from Randox. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
