AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUA...

FDA Device Recall #Z-3237-2017 — Class II — September 7, 2017

Recall Summary

Recall Number Z-3237-2017
Classification Class II — Moderate risk
Date Initiated September 7, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Radiometer America Inc
Location Brea, CA
Product Type Devices
Quantity 1669 Boxes

Product Description

AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers

Reason for Recall

Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the control range. (4.92  5.85 kPa or 36.9  46.9 mmHg) " pO2 give a considerable higher result than the expected assigned value of 13.9 -14.3 kPa (104-107 mmHg)

Distribution Pattern

Worldwide Distribution - US (nationwide) Internationally to Canada, Netherlands, China, Czech Republic, Denmark, Germany, Spain France, Hungary, India, Denmark, Tokyo, South Korea, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, and Finland.

Lot / Code Information

S7745 Lot R0698

Other Recalls from Radiometer America Inc

Recall # Classification Product Date
Z-2320-2019 Class II ABL90 FLEX Analyzer REF 393090 UDI:05700693930909 Jul 10, 2019
Z-0682-2019 Class II ABL800 analyzer, model numbers 393-800 and 393-... Jul 3, 2018
Z-0801-2019 Class II Product: ABL800 FLEX with Crea. The ABL800 with... Jul 2, 2018
Z-0010-2019 Class II ABL90 FLEX analyzers with software versions 3.3... May 25, 2018
Z-0231-2018 Class II ABL800 analyzer with FLEXQ module. Device in... Oct 24, 2017

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.