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Immunalysis
IMMUNALYSIS CORP · Model 310UR-0100 · UDI-DI 00840937101803
1
510(k) clearances
5
Adverse events
7
Recalls
86
Facilities
Description
Barbiturates Urine HEIA™
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.