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Rapid Response Multi-Drug Integrated Split Spec. Cup

BTNX Inc · Model D10.3-1K · UDI-DI 10722066005290

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10
510(k) clearances
62
Adverse events
24
Recalls
94
Facilities

Description

Multi-Drug Integrated Split Spec. Cup (D10.3-1K) - COC300 AMP1000 MET1000 THC50 OPI2000 PCP25 BAR300 BZO300 MTD300 MDMA500.

Recalls

DateFirmReason
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2020-08-18Ameditech IncVarious immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling.
2017-11-14Alere San Diego, Inc.The recalled lots have demonstrated unexpected false positive THC results.
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphi
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphi
2014-09-23Ameditech IncAmeditech is recalling the ArcPoint Labs Dip Drug Screen Dip Card because the positive interpretation illustration was incorrect on the cap labels as well as on the card cap graphi
2013-07-29Sarken, Inc.These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and i
2013-07-29Sarken, Inc.These products are being recalled because they were distributed without adequate labeling and instructions for use. Inadequate labeling could lead to misuse of the Test Kits and 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.