Device product
The ABL800 Model#:All
Z-1463-2017
Product summary
- Event
- Event 76339
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,522
- Official record key
device-enforcement:Z-1463-2017
Official wording
Reason: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.
Code information: The affected analyzers are serial numbers 393-090R0027N001 to present.
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.
Derived failure modes
-
Unknown
Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.