FDAFDA · Food and drugs·Recall number Z-1462-2017
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
Published March 22, 2017 · Recall initiated: January 26, 2017
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
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Radiometer America Inc
- Distributor
- U.S. distribution to the following; nationwide. Foreign distribution to the following; Netherlands, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, India, Japan, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland.
- Lot
- The affected analyzers are serial numbers 393-090R0027N001 to present.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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