Lower riskMedical device recall · FDA · Published November 22, 2022
Randox Liquid Assayed Specific Protein Control Level 2 recall: Risk of delayed test
Randox recalls specific protein control levels 2 for potential delayed test results due to reduced rheumatoid factor concentration. Affected units have catalog numbers PS2683 and GTIN 05055273204902.
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 Liquid Assayed Specific Protein Control Level 2 recall: Risk of delayed test.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59294-randox-liquid-assayed-specific-protein-control-level-2-recall-risk. Based on FDA recall #Z-0904-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0904-2023%22&limit=1).
The FDA announced on Nov. 22, 2022, that Randox Laboratories Ltd. is recalling Liquid Assayed Specific Protein Control Level 2 due to decreased Rheumatoid Factor concentration. This defect may cause quality controls to run outside the acceptable range, potentially delaying the reporting of test results.
How to tell if you have it
Brand: Randox
Product: Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems
Catalog Number: PS2683
UPC: 05055273204902
Lot Numbers/Exp. Dates: 585LPC (28th Jun 23), 601LPC (28th Nov 23), 612LPC (28th Sep 24)
Distribution: US Nationwide in CA, FL, OH, ME, MO, NC, NJ, PA, TN
Units affected: 115
The hazard
The concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3. This issue causes quality controls to run low outside the range, which can lead to a delay in reporting results.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since June 7, 2017. Recent brand recalls include a March 5, 2024 recall for Clinical Chemistry Calibration Serum regarding an Inorganic Phosphate Bias Issue and an April 5, 2024 recall for Evidence MultiSTAT Software v3.7 due to light leak risk. Other recent recalls of similar products include the July 29, 2026 Diagnostica Stago STA Staclot Protein S Recall (QC Value Drift Risk), the Nov. 22, 2025 Vivoo Protein Test Recall (False Results Risk Wrong Medical Treatment), and the Nov. 18, 2025 HemosIL SynthAFax Partial Thromboplastin Time Tests Recall (Double Preservative Risk).
How to tell if you have this one
Check for catalog number PS2683 or GTIN 05055273204902 on the product label. Lot numbers 585LPC (exp. 28 Jun 2023), 601LPC (exp. 28 Nov 2023), or 612LPC (exp. 28 Sep 2024) are affected.
Brand
Randox
Product
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.
Recall number
Product, codes & lots
Quantity
Z-0903-2023
Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1; GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;
146 units US
Z-0904-2023
Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683; GTIN: 05055273204902 Lot Number/Exp. Date: 585LPC 28thJun 23; 601LPC 28th Nov 23; 612LPC 28th Sep 24
115 units
Z-0905-2023
Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684; GTIN: 05055273204919 Lot Number/Exp. Date: 586LPC 28th Jun 23; 602LPC 28th Nov 23; 628LPC 28th Dec 24;
49 units US
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for catalog number PS2683 or GTIN 05055273204902 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 9 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Maine, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0904-2023 (November 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0904-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.