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enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vit...

FDA Device Recall #Z-1741-2014 — Class II — April 17, 2014

Recall Summary

Recall Number Z-1741-2014
Classification Class II — Moderate risk
Date Initiated April 17, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ortho-Clinical Diagnostics
Location Rochester, NY
Product Type Devices
Quantity Domestic: 6 units, Foreign: 3 units

Product Description

enGen (TM) Laboratory Automation System Configured with TCAutomation" Software v3.5 -- For in vitro quantitative measurement of a variety of analytes of clinical interest --- The VITROS 5,1 FS Chemistry System with enGenTM Laboratory Automation System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods.). ---The enGen (TM) Lab Automation System is a modification to VITROS Analyzers that includes the addition of an automated track sub-system (TCAutomation) for pre-analytical and post-analytical sample and data management. In addition to an Automated Track Sub-system, the enGen (TM) System includes one or more VITROS Chemistry, Immunodiagnostic and/or Integrated Systems (clinical analyzers) as well as a Data Management Subsystem (Middleware), and a Software Configuration (gsb) File. The enGen System is typically interfaced with a Laboratory Information System (LIS) via connectivity facilitated at the Data Management Subsystem level. By using the enGen (TM) Laboratory Automation System as a communication interface between the LIS and the clinical analyzers in the laboratory, the user can manage the workflow to the analyzers and other devices as an integrated system. This eliminates the need for the user to program tests for each sample uniquely on each analyzer. Within the enGen (TM) Laboratory Automation System, the physical routing of samples to the correct location is also automatic. The Buffer Module functions either as a location for samples waiting for results or as a storage area for empty sample tube carriers. When a sample is presented to a clinical analyzer via the Bypass module and is metered for testing, the sample remains on the track system in the Buffer module while waiting for the test results to be generated. If all test results are generated as expected and no additional actions are required, the sample is routed to a designated Exit module where it can be removed from the track system by the user. However, there are certain situations in which a follow-up action (retest of the sample) may be necessary. In these situations, the sample is routed back to a clinical analyzer via the Bypass module to complete the follow-up action. Examples of situations requiring a retest include, but are not limited to: repeat testing when a "No Result"is generated during the initial test event, sample dilution when an out of range result is obtained during the initial test event, and routing to an alternate analyzer when the first analyzer the sample is sent to is unavailable for testing. Once the follow-up sample metering actions are complete, the sample is routed to Buffer module where it remains until testing is complete. Once all test results are obtained the sample is routed to the designated Exit module.

Reason for Recall

Software anomaly: potential buffer timeout issues when using enGen (TM) Laboratory Automation Systems Configured with TCAutomation (TM) Software v3.5.

Distribution Pattern

Worldwide Distribution - US including the states of Arizona, Delaware, Ohio, Tennessee, and North Carolina; and the countries of Mexico, England and Italy.

Lot / Code Information

enGen (TM) Laboratory Automation Systems configured with TCAutomation" Software version 3.5

Other Recalls from Ortho-Clinical Diagnostics

Recall # Classification Product Date
Z-1372-2024 Class II VITROS Performance Verifier I Feb 27, 2024
Z-1373-2024 Class II VITROS Performance Verifier II Feb 27, 2024
Z-2358-2023 Class II VITROS Immunodiagnostic Products Troponin I ES ... Jun 5, 2023
Z-2357-2023 Class II VITROS Immunodiagnostic Products Troponin I ES ... Jun 5, 2023
Z-2129-2023 Class II VITROS Chemistry Products Calibrator Kit 20-in ... May 8, 2023

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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