ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX recall
ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
Why was ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 393-090, all production runs, 393-090R0026N0010 to 393-090R0179N010
- Product
- ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
- Recalling firm
- Radiometer America Inc
- Quantity
- 1427 ABL 90 Instruments
- Distribution
- 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.
- Recall date
- August 15, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)