Lower riskMedical device recall · FDA · Published December 13, 2019
Randox Liquid Clinical Chemistry Control: Incorrect Lipase Value in Lot 1021UE
Randox recalls Liquid Clinical Chemistry Control (LAE4217) due to incorrect lipase value in specific lot. This may affect lab test accuracy. No action needed for most users.
A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
“Randox Liquid Clinical Chemistry Control: Incorrect Lipase Value in Lot 1021UE.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66323-randox-liquid-clinical-chemistry-control-incorrect-lipase-value-in-lot. Based on FDA recall #Z-1100-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1100-2020%22&limit=1).
Randox Laboratories Ltd. recalled Liquid Clinical Chemistry Control, Catalogue Number LAE4217, Size 12 x 5 ml, due to a transcription error in the Lipase colorimetric value, according to the FDA on Dec. 13, 2019.
How to tell if you have it
Brand: Randox
Product: Liquid Clinical Chemistry Control
Catalogue Number: LAE4217
Size: 12 x 5 ml
UPC: 05055273208993
Lot Number: 1021UE (EXP: 2020-06-28)
The hazard
A transcription error occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range were listed as 50 U/L (40 - 60) but should be 72U/L (58 - 86).
Context
GovInfoNow's records show Randox Laboratories Ltd. has 49 other recalls on record since 2017-06-07. Other recent recalls include the Randox Cystatin C Reagent Recall (2024-06-07), the Randox Evidence MultiSTAT Software v3.7 Recall (2024-04-05), and the Randox Clinical Chemistry Calibration Serum Recall (2024-03-05). Other recent recalls of similar products include the Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (2026-05-07).
How to tell if you have this one
Check for the lot number 1021UE on the product label. The product is labeled as Liquid Clinical Chemistry Control, Catalogue Number LAE4217, with an expiration date of June 28, 2020.
Brand
Randox
Product
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot number 1021UE on the product label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in Delaware and New York, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Delaware, New York.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
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-1100-2020 (December 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1100-2020 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.