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eREADER™

ESCREEN, INC. · Model E&I V3 - New · UDI-DI 00860429001046

JJQ
10
510(k) clearances
355
Adverse events (1 deaths)
17
Recalls
88
Facilities

Description

The eScreen eREADER™ is a sophisticated appliance that uses digital technology to scan the test lid of a sealed eCup, providing an automated, objective, confidential testing process. The eREADER™ uses bar code technology, coupled with optical imaging, to electronically capture the drug test results from eCups without the subjectivity of a clinician reading them. Within 15 minutes, the eREADER™ automatically reports a negative eCUP™ urine drug screen back to you via your account or another applicant tracking system.

Recalls

DateFirmReason
2025-09-23Becton Dickinson & Co.Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar
2022-10-03Beckman Coulter, Inc.Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2016-07-25Tecan US, Inc.The batteries have the potential to overheating, melt or char.
2011-01-12QIAGEN Gaithersburg, Inc.The software component of a diagnostic medical device may be defective and could cause incorrect patient values.
2009-03-12BioTek Instruments, Inc.Software design allowed false negatives to be read when wells are dark.

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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.