Z-1462-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2017
- Initiation Date
- January 26, 2017
- Termination Date
- February 20, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,688
Product Description
ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.
Reason for Recall
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Distribution Pattern
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.
Code Information
The affected analyzers are serial numbers 393-090R0027N001 to present.