Lower risk Medical device recall · FDA · Published August 9, 2019

Randox Liquid Protein Calibrators Recall: Inaccurate Rheumatoid Factor Measurements

Randox recalls liquid protein calibrators (SP CAL (LIQ)) due to inaccurate Rheumatoid Factor measurements. Affected units may cause incorrect test results for certain blood tests.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0283-2020Medical device Randox ›

Lower-risk recall

The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to re-align to the reference material.

Take action

Contact the company

Recalling firmRandox Laboratories Ltd.55 Diamond Road · Crumlin (North), Ireland

✎ GovInfoNow plain-language explainer

Randox is recalling liquid protein calibrators used in blood tests because they provide inaccurate Rheumatoid Factor measurements. This could lead to incorrect test results for certain blood tests. Read more at govinfonow.com/recall/67231-randox-liquid-protein-calibrators-recall-inaccurate-rheumatoid-factor-measurements.

Source Summary by GovInfoNow · govinfonow.com/recall/67231-randox-liquid-protein-calibrators-recall-inaccurate-rheumatoid-factor-measurements · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0283-2020

Cite this page

“Randox Liquid Protein Calibrators Recall: Inaccurate Rheumatoid Factor Measurements.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67231-randox-liquid-protein-calibrators-recall-inaccurate-rheumatoid-factor-measurements. Based on FDA recall #Z-0283-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0283-2020%22&limit=1).

The FDA announced on 2019-08-09 that Randox Laboratories Ltd. is recalling Liquid Protein Calibrators (SP CAL (LIQ)) due to inaccurate calibration values. The agency said the calibrator values had been adjusted to re-align with reference materials.

How to tell if you have it

Brand: Randox
Product: Liquid Protein Calibrators (SP CAL (LIQ))
Catalogue Number: IT2691
GTIN/UPC: 05055273204032
Lot Codes: 440973 /1748, 1752IT, 451414 /1748, 1752IT, 470531 /1813, 1817IT, 480859 /1813, 1817IT
Distribution: US Nationwide in WV, ME, NJ, CA, and Puerto Rico

The hazard

The FDA said the assigned value for Rheumatoid Factor over-recovered against the reference material RF serum. The calibrator values have been adjusted to re-align to the reference material.

Context

GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Recent brand recalls include a 2024-06-07 Cystatin C Reagent recall for missing FDA 510(k) and a 2024-04-05 Evidence MultiSTAT Software v3.7 recall for light leak risk. Other recent recalls of similar products include Siemens Dimension Creatinine Flex Reagent Cartridge Recall (2026-03-18), Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (2025-12-11), and Fujirebio Lumipulse G pTau 217 Plasma Calibrators (2025-12-11).

How to tell if you have this one

Look for the product name 'Liquid Protein Calibrators (SP CAL (LIQ))' with Catalogue Number IT2691 and GTIN 05055273204032. The affected batches include 440973 /1748, 1752IT, 451414 /1748, 1752IT, 470531 /1813, 1817IT, and 480859 /1813, 1817IT.

Brand
Randox
Product
Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032
Category
Medical device

FDA recall event · 2 products

All 2 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
Terminated
Distribution
US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.

Recall number	Product, codes & lots	Quantity
Z-0282-2020	Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.; Batch/Lot # 463479/1325 -1329RF 466715/1325 -1329RF 474059/1339 1343RF 480410/ 1347 1351RF	17 kits
Z-0283-2020	Liquid Protein Calibrators (SP CAL (LIQ)) Catalogue Number: IT2691 GTIN: 05055273204032 Product Usage: Liquid Protein Calibrators are intended for in vitro diagnostic use in the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays on Clinical Chemistry and Immunoassay systems, Abbott Spectrum, Abbott Aeroset, Abbott Architect i2000, Architect i2000sr, Ace analyser, Bayer Advia 1650, Advia 2400, Advia 1200, Dade Dimension RXL, Dimension AR, Hitachi 704, Hitachi 717, Hitachi 911, Hitachi 917, Hitachi 912, Hitachi 747, Kone progress, AU800, AU600, AU400, AU2700, AU5400, Selectra Vitalab, Synchron CX4, Synchron CX5, Synchron CX7, Synchron LX20, ILAB300, ILAB900, ILAB1800, ILAB600, RX Daytona, RX Imola, Cobas Mira, Cobas Mira S, Cobas Mira Plus systems; Batch/Lot # 440973 /1748 1752IT 451414 /1748 1752IT 470531 /1813 1817IT 480859 /1813 1817IT	100 kits

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the Catalogue Number (IT2691) and GTIN (05055273204032) on the product label.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

FDA distribution: “US Nationwide distribution in the states of WV, ME, NJ, CA, and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Maine, New Jersey, Puerto Rico, West Virginia.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

Aug 9, 2019Firm started the recall
Nov 4, 2019FDA classified it Class II
Nov 13, 2019Published in FDA’s Enforcement Report
Jan 8, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Which blood tests are affected?

The calibrators are used for in vitro diagnostic tests on Clinical Chemistry and Immunoassay systems, including ASO, Complement C3, Complement C4, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Prealbumin, and Transferrin assays.

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Link to this recall

<a href="https://govinfonow.com/recall/67231-randox-liquid-protein-calibrators-recall-inaccurate-rheumatoid-factor-measurements">Randox Liquid Protein Calibrators Recall: Inaccurate Rheumatoid Factor Measurements (GovInfoNow)</a>

Where this comes from

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-0283-2020 (August 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0283-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.