Food, drugs, devices › Randox Laboratories
Device recall: Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clini
FDA enforcement event 77152 is a device recall by Randox Laboratories of Kearneysville, WV, initiated 27 Apr 2017 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 14 Aug 2017. Initiation: voluntary: firm initiated. Randox Laboratories has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Randox Laboratories, Kearneysville, WV.
Reason for recall
"According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted…"
Distribution
"Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2167-2017 | Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems. | 198 kits | Class III | Terminated | 7 Jun 2017 |
Context
Other enforcement events for Randox Laboratories
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 1 Feb 2023 | CRP Immunoturbidimetric reagent. Intended for the quantitative in vitro determination of CRP concentration in serum Cata | Device | Class II | 1 |
| 4 May 2018 | RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests. | Device | Class II | 1 |
| 11 Aug 2017 | Immunoassay Premium Controls (3x4x5mL and 12x5mL packages) | Device | Class III | 2 |
| 16 Sep 2016 | The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin | Device | Class II | 1 |
All 5 events for Randox Laboratories
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of Total Protein (urine). The values for the mean of all instruments are incorrect by a factor of 10. Instrument specific values are correct. This does not affect the performance or stability claims of the product. As control results will be outside of the quoted…"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Aug 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.