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QuikScreen
SYNTRON BIORESEARCH, INC. · Model 60510 · UDI-DI 00748349000113
1
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities
Description
QuikScreen Multi 5 Drug Cup Test - AMP 1000, BZD 300, COC 300, OPI 2000, THC 50
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-15 | Ameditech Inc | The kit box label incorrectly identifies Phencyclidine (PCP), where it should list Tricyclic Antidepressants (TCA) as one of the 10 drug analytes included in the kit box. |
| 2017-06-26 | Ameditech Inc | The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes included in the kit. The pouch label, product insert, and the device itself are labeled |
| 2003-11-17 | Abbott Health Products, Inc. | Drug product cross reacts with the Tricyclic Antidepressants (TCA) assay. |
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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.