Lower riskMedical device recall · FDA · Published February 7, 2019
Randox LIA310: Incorrect Target Value May Affect Lab Test Accuracy
Randox recalls LIA3105 liquid immunoassay controls for inaccurate test results. The target value is listed incorrectly on the value sheet, potentially causing inaccurate lab diagnostics.
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
“Randox LIA310: Incorrect Target Value May Affect Lab Test Accuracy.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69039-randox-lia310-incorrect-target-value-may-affect-lab-test-accuracy. Based on FDA recall #Z-1107-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1107-2019%22&limit=1).
The Food and Drug Administration announced on Feb. 7, 2019, that Randox Laboratories Ltd. voluntarily recalled its Liquid Immunoassay Premium Controls due to an incorrect target value on the analyzer's value sheet. The agency classified the Class III recall as terminated.
How to tell if you have it
Brand: Randox
Product: Liquid Immunoassay Premium Controls
Model Number: LIA3105
Lot Code: 1723EC
The hazard
The target value for uptake is listed as 43.8%U on the value sheet but should be 39.4%U, according to the FDA recall record. The product is intended for in vitro diagnostic use as assayed quality control material.
Context
GovInfoNow's records show Randox Laboratories Ltd. has issued 49 other recalls since June 7, 2017. Recent actions include a March 5, 2024, recall of Clinical Chemistry Calibration Serum for an inorganic phosphate bias issue and an April 5, 2024, recall of Evidence MultiSTAT Software v3.7 due to light leak risks. A June 7, 2024, recall addressed a missing FDA 510(k) for Randox Cystatin C Reagent.
How to tell if you have this one
Check for the model number LIA3105 on the product label. These controls were sold with lot code 1723EC for in vitro diagnostic use.
Brand
Randox
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 III
Status
Terminated
Distribution
The products were distributed to the following US states: WV and Puerto Rico.
Recall number
Product, codes & lots
Quantity
Z-1105-2019
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert; Lot codes: 440941 1720EC
58
Z-1106-2019
Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert; Lot codes: 1714EC 430312 432364
12
Z-1107-2019
Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert; Lot codes: 1723EC
4
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number LIA3105 and lot code 1723EC on the product label.
Where it went and when
Where it was distributed
Distributed in Puerto Rico and West Virginia.
Listed by the agency
Not listed
FDA distribution: “The products were distributed to the following US states: WV and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Puerto Rico, West Virginia.
Recall timeline
FDA terminated this recall 16 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-1107-2019 (February 7, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1107-2019 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.