FDA Medical Device Recalls (openFDA)
Radiometer America Inc: ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
- Recall number
- Z-0816-2014
- Recalling firm
- Radiometer America Inc
- Product
- ABL90 FLEX Analyzer Radiometer Medical ApS, kandevej 21 Brnshj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
- Status
- Terminated
- Initiated
- 2013-10-15
- Posted
- 2014-01-23
- Terminated
- 2014-06-19
- Reason
- RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
- Root cause
- Other
- Action
- Radiometer sent an Urgent Medical Device Recall letter dated November 5, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check all of their ABL90 FLEX analyzers and ensure that the analyzer is placed on a horizontal platform/table. If the analyzer is placed on a roll stand, please ensure that the support plate is aligned horizontally and locked in this position. Customers were asked to complete and fax the accompanying acknowledgment form in order to confirm their receipt of this field safety notice. Customers with questions were instructed to contact Radiometer America Technical Support at 1-800-736-0600, option 4. For questions regarding this recall call 440-871-8900.
- Quantity
- Total 3414 (US 524, CA 31, ROW 2859)
- Distribution
- 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, serial or model codes
- Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
- 510(k) numbers
- ["K092686"]
- PMA numbers
- not on file
- Product code
- JGS
- Firm FEI
- 1523456
- Firm city
- Westlake
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28