Recall record at a glance
| Official record | Z-2077-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ortho-Clinical Diagnostics |
| Report date | May 24, 2017 |
| Recall initiation date | Mar 8, 2017 |
| Quantity | US: 33 units; OUS: 43 units |
| Location | Rochester, NY, United States |
Official product description
enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software Versions with the InOut Communication Interface, IVD
Why the product 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.
Distribution information
MA, NJ, NY, NY, PA,DE, MD, WV, NC, GA, FL, TN, MS, OH, MI, IL, MO, NE, AR, TX, CO, ID, TX, CA and Foreign distribution to the following countries: Belgium, Bermuda, Brazil, Canada, Chile, Denmark, England, France, Italy, Mexico, Norway, Portugal, Romania, Singapore, Spain, Sweden, Taiwan, United Kingdom.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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