Z-1463-2017 Class II Terminated
FDA device recall Z-1463-2017 was initiated by Radiometer America Inc on January 26, 2017 and is designated Class II. 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. The recall status is terminated (terminated February 20, 2018). Affected quantity: 17,522.
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
- 17,522
Product Description
The ABL800 Model#:All
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.