Reported May 24, 2017 · Terminated
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication…
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
- Lot codes and dates
75 of 75 products · 75 lot codes
Recalled lot codes, grouped by product number US Serial Numbers J Numbers B3ZHP2JJB3ZHP2J
736BM4JJ736BM4J
953289J953289
953252J953252
HJ5K84JJHJ5K84J
FCM073JJFCM073J
HPKG25JJHPKG25J
GWXQ52JJGWXQ52J
GBX395JGBX395J
JFBX395JJFBX395J
- Amount recalled
- US: 33 units; OUS: 43 units
Where it was sold
Why it was recalled
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.) A Radio Frequency Identification (RFID) Tag Read failure occurs on the Sample A carrier, and (4.) The VITROS System is not available to aspirate on the track (for example, the analyzer is initializing, or the user is making entries on the diagnostic screen, or samples are being aspirated from the front of the analyzer, etc.). --- If the software anomaly occurs and the issue is present, the Sample ID in the INOUT communication device software queue becomes asynchronous with the actual Sample ID physical queue, and the VITROS assay result will be reported for the wrong Sample ID. All subsequent samples will have miss-associated results until the Bypass module is reset or the queue is empty. --- This issue could potentially miss-associate a sample/patient ID with a test result of a different sample. Depending on the test involved, patients health condition, etc., the potential health risk posed to the affected patient could range from no risk to serious risk, and potentially could lead to misdiagnosis or inappropriate medical intervention. To date, no patient harm was reported related to this product issue.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new seafood recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.