ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automat...

FDA Device Recall #Z-0816-2014 — Class II — October 15, 2013

Recall Summary

Recall Number Z-0816-2014
Classification Class II — Moderate risk
Date Initiated October 15, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Radiometer America Inc
Location Westlake, OH
Product Type Devices
Quantity Total 3414 (US 524, CA 31, ROW 2859)

Product Description

ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

Reason for Recall

RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.

Distribution Pattern

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.

Lot / Code Information

Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010

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.