FDAFDA · Food and drugs·Recall number Z-2164-2012
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Published August 15, 2012 · Recall initiated: July 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- 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.
- Lot
- Part Number: 393-090, all production runs, 393-090R0026N0010 to 393-090R0179N010
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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