Company: Ortho-Clinical Diagnostics.
Date of Enforcement Report 5/24/2017
Class lI:
PRODUCT
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Recall Number Z-2077-2017
REASON
Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, subsequently, confirmed a software anomaly that may potentially result in miss-associated sample IDs involving the communication between enGen TCAutomation (TCA) Bypass modules (manufactured by Thermo-Fisher Scientific) and the VITROS Analyzers. To date, no occurrences of this issue have been observed on Orthos enGen(TM) Systems.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 3/8/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
US: 33 units; OUS: 43 units
DISTRIBUTION
Nationwide and Internationally.
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