Randox recalls Clinical Chemistry Calibration Serum (Cal2351) due to potential inorganic phosphate bias on RX Series instruments. Affected lots may cause inaccurate test results. Contact Randox for details.
Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
Randox is recalling a clinical chemistry calibration serum that may cause inaccurate test results on certain instruments. This affects labs using specific lots of the serum, which could lead to incorrect patient test results if not addressed.
The serum contains inorganic phosphate that shows a negative bias when measured on RX Series instruments. This means test results could be inaccurate, potentially leading to incorrect patient diagnoses or treatment decisions.
Labs using Randox Clinical Chemistry Calibration Serum (Cal2351) with specific lots may be affected. Users most at risk are laboratory technicians handling these serum samples.
Check for the catalog number Cal2351 or Cal10388 on the serum container. Affected lots include 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, and 1326UE.
Look for the lot numbers 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, or 1326UE on the serum container.
The serum shows a negative bias in inorganic phosphate measurements on RX Series instruments, which could lead to inaccurate test results.
Affected lots include 1260UE, 1262UE, 1295UE, 1297UE, 1298UE, 1315UE, 1325UE, and 1326UE.
No immediate stop is required, but labs should check the lot number and contact Randox if they have affected lots.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-1759-2024 — Randox Randox Hello, I own a Randox that is covered by recall Z-1759-2024 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.
