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Terminated

ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

FDA Recall Z-1046-2015 · Posted 2015-02-09

Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-12-08
Date Terminated2015-09-23
Product Quantity5002 units

Reason for Recall

The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.

Firm Action

Radiometer sent a Field Safety Notice dated December 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. What you should do short term: " Please ensure that the operator always closes the inlet when prompted by the analyzer, as per the labeling. " In case the inlet, by mistake, is not closed as per the labeling, please ensure that the following is carried out before measuring a patient sample: " Close the inlet and wait for the analyzer to go to READY (approximately five minutes) " Open the inlet and then close again (to initiate a Rinse) " Wait for the analyzer to go to READY (approximately 1 minutes) " Please return the confirmation fax form no. 1 to your RADIOMETER representative when the above actions have been implemented Final Solution provided by RADIOMETER: A mechanism will be provided in an upgraded version of the analyzer software to eliminate the possibility of this error. The new software version will be installed by your local engineer when available. Customers were instructed to ensure that this letter is distributed to the final end-user. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, opt 4.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -USA including CT, MN, FL, CA, PA, NY, KY, MA, WA, MI, TX, NC, IL, OH, SC, OK, NJ, MD, VA, UT, AL, NM, GA, LA, OR, IN, WI, AZ, ND, CO, MO, WV, ID, TN, VT, NE, IA, NH, MS, ME, AR and Internationally to Canada, Australia, Austria , China, Czech Republic, Denmark, Estonia, Lithuania, Romania, Slovenia, United Arab Emirates, Bolivia, Brazil, Indonesia, Israel, Kuwait, Malaysia, Mexico, Peru, Qatar, Saudi Arabia, Serbia and Montenegro, Syrian Arab Republic, Thailand, Vietnam, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Republic of Korea, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120197ABL90 FLEXRadiometer Medical Aps · 2012-03-19

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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