IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can rece...

FDA Device Recall #Z-0203-2019 — Class II — August 29, 2018

Recall Summary

Recall Number Z-0203-2019
Classification Class II — Moderate risk
Date Initiated August 29, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Data Innovations, LLC
Location South Burlington, VT
Product Type Devices
Quantity 9

Product Description

IM Abbott Alinity ci-series (abdicqii) accessory driver v8.00.0001 software product that can receive information from a hospital computer system (also called a Laboratory Information System [LIS]).

Reason for Recall

Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This has been determined to be a driver malfunction. When an instrument transmits results from a quality control (QC) sample ID ("Q^Control" in SPM segment), and the option Hold Results Until Complete is enabled, the results do not parse into IM. The communication Trace shows the sample being transmitted, but no information is logged in the Specimen Event Log (SEL). There is a potential for harm if QC results are not processed, downstream auto verification rules may misfire based on missing QC results leading to a delay in, or incorrect treatment. QC results will not be available for evaluation by the lab. There have been no reported instances of patient harm from this malfunction.

Distribution Pattern

Distributed to OK. Foreign distribution to Argentina, Hong Kong, Malaysia, Thailand, Germany, Jordan, Australia, and Switzerland.

Lot / Code Information

accessory driver version number 8.00.0001

Other Recalls from Data Innovations, LLC

Recall # Classification Product Date
Z-1680-2017 Class II JResultNet drivers using ASTM coding language. ... Oct 23, 2014
Z-2637-2014 Class II ProVue Instrument Driver for JResultNet (ProVue... Aug 15, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

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.