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CLIAwaived
Cliawaived, Inc. · Model CLIA-SDDT-21 · UDI-DI 00816610020235
LFH
Prescription
1
510(k) clearances
1
Adverse events
3
Recalls
7
Facilities
Description
Single Drug Dipstick Test for TCA1000
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.