Lower riskMedical device recall · FDA · Published November 19, 2018
Randox SP CAL (LIQ) recall: Calibrator value sheet updates for diagnostic tests
Randox recalls SP CAL (LIQ) REF IT2692 due to calibrator value sheet updates for Alpha-1-Acid-Glycoprotein and IgG tests. This affects in vitro diagnostic use with specific assays.
Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.
“Randox SP CAL (LIQ) recall: Calibrator value sheet updates for diagnostic tests.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69452-randox-sp-cal-liq-recall-calibrator-value-sheet-updates-for. Based on FDA recall #Z-0660-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0660-2019%22&limit=1).
The FDA announced on 2018-11-19 that Randox Laboratories Ltd. voluntarily recalled SP CAL (LIQ), REF IT2692, a diagnostic calibrator. The agency stated the recall was initiated because calibrator value sheets were modified for assigned values of Alpha-1-Acid-Glycoprotein, IgA and IgG to improve alignment. IgG measurement references were also corrected.
How to tell if you have it
Brand: Randox
Product: SP CAL (LIQ), REF IT2692
Lot Number: 415879
Date of Expiry: 28 March 2019
UPC: 05055273204049
The hazard
According to the FDA, calibrator value sheets have been modified for assigned values of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve alignment. The IgG measurement reference has also been corrected.
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Other recent recalls of similar products include Randox Cystatin C Reagent Recall (2024-06-07), Randox Evidence MultiSTAT Software v3.7 Recall (2024-04-05) and Randox Clinical Chemistry Calibration Serum Recall (2024-03-05).
How to tell if you have this one
Check for the product name SP CAL (LIQ) with reference number IT2692. This calibrator is used with Randox Alpha-1-Antitrypsin, Alpha-1-Acid Glycoprotein, IgA, IgG, and IgM assays that require sample predilution.
Brand
Randox
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product name and reference number on the calibrator label.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of : IN, NJ, NY, TX and WV and internationally to Ireland.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, New Jersey, New York, Texas, West Virginia.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-0660-2019 (November 19, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0660-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.