Randox recalls specific batches of Liquid Assayed Specific Protein Control Level 3 for in vitro diagnostics. Low Rheumatoid Factor concentration may cause delays in test results. Affected batches have catalog numbers PS2684 and lot numbers 586LPC, 602LPC, 628LPC.
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 batches of their Liquid Assayed Specific Protein Control Level 3 used in clinical testing. The product may have lower Rheumatoid Factor concentration, which can cause test results to run outside acceptable ranges and delay reporting. This affects laboratory users who rely on this control for quality checks.
The control product may have decreased Rheumatoid Factor concentration, causing quality control tests to run outside the acceptable range. This can lead to delays in reporting test results because the system may not properly detect abnormalities in patient samples.
Laboratories using Randox's Liquid Assayed Specific Protein Control Level 3 for clinical testing are affected. Users who have the specific batch numbers listed in the recall are most at risk of delayed test results.
Check for catalog number PS2684 and lot numbers 586LPC (expires June 23, 2023), 602LPC (expires November 23, 2023), or 628LPC (expires December 24, 2024) on the product label.
Look for catalog number PS2684 and lot numbers 586LPC, 602LPC, or 628LPC on the product label.
The concentration of Rheumatoid Factor has decreased in this product, causing delays in test results due to quality control systems running outside acceptable ranges.
Check the product label for catalog number PS2684 and lot numbers 586LPC, 602LPC, or 628LPC. If you have these, contact Randox for guidance.
No, this is a low-risk recall related to test result delays, not physical harm.
We’ve drafted a message you can send Randox to request your refund or repair — edit it as you like.
Subject: Recall Z-0905-2023 — Randox Randox Hello, I own a Randox that is covered by recall Z-0905-2023 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.
