CLASS III Device recall · Reported 2 Oct 2019 · FDA Enforcement Report
Randox Urinalysis Control Level 2 (IVD) recalled by Randox Laboratories
Randox Laboratories is recalling Randox Urinalysis Control Level 2 (IVD), distributed nationwide in the US. The recall was initiated on 25 Jul 2019 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2557-2019
- FDA event ID
- 83592
- Recalling firm
- Randox Laboratories, Crumlin (North)
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Jul 2019
- FDA classified
- 23 Sep 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 25 Jul 2019 | Recall initiated by company | |
| 23 Sep 2019 | Classified by FDA | +60 days |
| 2 Oct 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Product as listed by the FDA
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Where it was distributed
US Nationwide distribution including the states of IN, WV.
Questions about this recall
Is Randox Urinalysis Control Level 2 (IVD) recalled?
Yes. Randox Laboratories recalled Randox Urinalysis Control Level 2 (IVD) on 25 Jul 2019. The recall is Class III and its status is Terminated. Recall number Z-2557-2019.
Why was it recalled?
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Which lots are affected?
Lot: 1020UC Exp. Date: 28 May 2020
Where was it sold?
US Nationwide distribution including the states of IN, WV.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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