Recall Z-0816-2014
Radiometer America Inc · initiated October 15, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010
Reason for recall
RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-0816-2014
- Initiated
- October 15, 2013
- Posted by FDA
- January 23, 2014
- Terminated
- June 19, 2014
- Product code
- JGS – Electrode, Ion Specific, Sodium
- 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…
- Recalling firm
- Radiometer America Inc, Westlake, OH