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URINALYSIS CONTROL - LEVEL 1 (URNAL CONTROL 1)
RANDOX LABORATORIES LIMITED · Model UC5033 · UDI-DI 05055273207583
JJW
Prescription
10
510(k) clearances
31
Adverse events
22
Recalls
36
Facilities
Description
This product is intended for in vitro diagnostic use, in the quality control of urine test strips.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-22 | Changchun Wancheng Bio-Electron Co., Ltd. | Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause fa |
| 2024-09-17 | Mckesson Medical-Surgical Inc. Corporate Office | The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay i |
| 2024-07-16 | Beckman Coulter, Inc. | Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results whe |
| 2022-11-18 | Beckman Coulter, Inc. | Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iC |
| 2022-02-16 | Beckman Coulter, Inc. | IRISpec CA failures for glucose. |
| 2020-04-20 | Cardinal Health Inc. | Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdi |
| 2019-07-25 | Randox Laboratories Ltd. | Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+. |
| 2017-12-21 | Quantimetrix Corporation | The kits contained an incorrect lot of Dropper Plus Level 1 vials |
| 2014-02-06 | Lin-Zhi International Inc | Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards t |
| 2013-10-29 | Thermofisher Scientive | Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.