Randox recalls Specific Protein Control Levels 1-3 for potential delayed test results due to low concentration of Rheumatoid Factor. Affected units include specific lot numbers and dates.
Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range
Randox is recalling Specific Protein Control Levels 1-3 used in clinical testing because the Rheumatoid Factor concentration has decreased, which can cause delays in reporting test results. This affects labs that use these controls for quality checks in serum testing.
The Rheumatoid Factor concentration in these controls has decreased below the required level. This causes quality control tests to run outside the acceptable range, potentially delaying the reporting of test results for patients.
Labs and healthcare facilities that use Randox Specific Protein Controls for clinical chemistry testing are affected. Those handling the recalled control levels (1-3) are most at risk of delayed test results.
Check for the catalog number PS2682 and lot numbers 584LPC (exp. 28 Jun 2023), 600LPC (exp. 28 Nov 2023), or 611LPC (exp. 28 Sep 2024) on the product packaging.
Verify the catalog number PS2682 and lot numbers 584LPC, 600LPC, or 611LPC on the product packaging.
The concentration of Rheumatoid Factor has decreased in Specific Protein Control Levels 1-3, causing quality control tests to run outside the acceptable range and potentially delaying test results.
Check the product packaging for the catalog number PS2682 and lot numbers 584LPC, 600LPC, or 611LPC. If you have these, contact Randox for guidance.
No, this recall is for potential delayed test results, not a physical hazard. The product itself does not pose a risk of injury.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0903-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-0903-2023 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.
