FDAMarch 8, 2017device

enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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. Sample IDs may become miss-associated with the actual sample being processed due to discrepant information passed to the analyzer through InOut communication device, triggered by a specific set of events occurring between the Bypass module and the analyzer. --- All of the following conditions must be present for the issue to potentially occur: (1.) The Bypass module is in the process of positioning Sample A at the aspiration position, and (2.) At least two additional sample tubes (Samples B and C) are waiting to be aspirated in the Bypass module queue, and (3.

What to do

FDA enforcement status: Terminated

Brands named

ortho clinical diagnosticsorthoortho clinical

UPCs

38769917923

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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