Recall Z-1462-2017— Radiometer America Inc
Class II · Terminated
Class II FDA medical device recall by Radiometer America Inc, initiated 2017-01-26, terminated 2018-02-20. It names one FDA 510(k) clearance: K092686. Product: ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.. Reason: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous..
- Recalling firm
- Radiometer America Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-26
- Terminated
- 2018-02-20
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.