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Rapid Response

BTNX Inc · Model D5.30.1-1VA · UDI-DI 00722066005019

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1
510(k) clearances
56
Adverse events
81
Recalls
88
Facilities

Description

One Step DOA Cup + Adulteration Test (5.30.1) COC(150) EDDP(100) MOP(100) OXY(100) BZO(300) + CR/SG/pH

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.