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Evidence MultiSTAT DOA Urine MultiPlex
RANDOX LABORATORIES LIMITED · Model EV4393 · UDI-DI 05055273216752
1
510(k) clearances
5
Adverse events
7
Recalls
86
Facilities
Description
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-12 | Beckman Coulter Inc. | The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compo |
| 2018-05-18 | Guangzhou Wondfo Biotech Co., Ltd. | GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collect |
| 2018-05-18 | Guangzhou Wondfo Biotech Co., Ltd. | GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collect |
| 2018-05-18 | Guangzhou Wondfo Biotech Co., Ltd. | GUANGZHOU WONDFO BIOTECH discovered on the TCube One Step Multi-Drug Oral Fluid Test Cube the potential for failure of the saliva collection device. The use of the saliva collect |
| 2016-11-10 | OraSure Technologies, Inc. | Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing. |
| 2012-01-04 | Alere San Diego | Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA. |
| 2011-09-08 | Lin-Zhi International Inc | Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correc |
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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.