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EtOH CAL/CONTROL
RANDOX LABORATORIES LIMITED · Model DA2703 · UDI-DI 05055273207873
1
510(k) clearances
21
Adverse events
5
Recalls
40
Facilities
Description
The Randox Ethanol Calibrator and Control Set is intended for the calibration and quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-14 | Ortho-Clinical Diagnostics, Inc. | Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing |
| 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 |
| 2011-11-11 | Microgenics Corp | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
| 2011-06-08 | Microgenics Corp | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. |
| 2010-09-13 | Abbott Laboratories | The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment. |
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