FDA Device Intelligence
Home › Alere San Diego, Inc. › SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup

SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup

Alere San Diego, Inc. · Model DBO-1107-401 · UDI-DI 00810124273668

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

Description

(AMP1000/COC300/THC50)+(MET1000/OPI2000/PCP25)+(BZO300/TCA1000/BAR300)+<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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.