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FIRST SIGN®

HEMOSURE INC. · Model FSCCUP-654 · UDI-DI 00817763020523

JXMDJCDKEDIODJG Prescription
10
510(k) clearances
56
Adverse events
81
Recalls
89
Facilities

Description

DOA 5 in 1 Test Cup, 25Pcs/Box; First Sign for Hemosure; CLIA Waived BZO/COC/mAMP/OPI/THC

Recalls

DateFirmReason
2020-07-13OraSure Technologies, Inc.Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
2020-07-13OraSure Technologies, Inc.Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i
2015-11-16Ameditech IncAmeditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information i

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Data 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.