FDA-Device2012-08-15Class II
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Radiometer America Inc
Hazard
A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
Sold states
Worldwide distribution: USA (nationwide) including the states of AK, AL, AR, AZ, BM, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech republic, Denmark, Ecuador, Egypt, Eritrea, Estonia, Finland, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Malta, Mauritius, Mexico, Moldova, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Qatar, Republic of Korea, Romania, Russia, Saudi Arabia, Switzerland, Singapore, Slovenia, South Africa, Spain, Sweden Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Yugoslavia, and Zimbabwe.
Affected count
1427 ABL 90 Instruments
Manufactured in
810 Sharon Dr, Westlake, OH, United States
Products
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2164-2012Don't want to check this manually?
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