The ABL800 Model#:All
FDA Recall Z-1463-2017 · Posted None
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Recalling FirmRadiometer America Inc
Recall StatusTerminated
Product CodeCHL
Date Initiated2017-01-26
Date Terminated2018-02-20
Product Quantity17,522
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.
Firm Action
Customer notification letters were sent 01/27/16.
The letter provided the following instructions:
The firm recommends that customers ensure that operators and clinicians using the "cord blood sample results from a HIS/LIS or a middleware system to determine treatment are made aware that arterial or venous is not transmitted.
An upgraded version of the ABL90 and ABL800 series software will ensure that the full sample type cord blood arterial and cord blood venous will be transmitted to the HIS/LIS or middleware system. The new software version will be installed by local engineer when available.
If not the end user customers are instruction to provide a copy of the recall notification letter to the end user.
Any questions regarding this letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1.
Root Cause
Device Design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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