Liquid Urine Control Level 3 For Professional Use in the quality… — Class III medical device recall Z-2167-2017
Terminated recall by Randox Laboratories, reported 2017-06-07, distributed in PR. According to Randox Laboratories an investigation indicates a labelling error for 2 of the test methods listed
| Recall number | Z-2167-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Randox Laboratories, Kearneysville, WV, United States |
| Recall initiated | 2017-04-27 |
| Classified | 2017-05-26 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2017-08-14 |
| Distributed | PR |
| Countries outside the US | AE, CA, CL, CN, FR, GB, GT, IN, IQ, IR, IT, KW, PL, RO, SA, SI, UY |
| Quantity | 198 kits |
| Reason classes | specification failure |
| Lot numbers | 907UC |
| Model numbers | UC5075 |
Product
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.
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 range this may result in a delay in reporting the sample test results. However as the correct instrument specific means are also included in the value sheet this delay is unlikely. Customers have been referred to their Medical Director for further advice
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2167-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.