Device product
RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for comprehensive lab-quality testing to patient's bedside. Test menu includes blood gas, electrolytes, glucose, lactate, neonatal total bilirubin and full CO-oximetry including total hemoglobin.
Z-2930-2018
Product summary
- Event
- Event 80516
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2357
- Official record key
device-enforcement:Z-2930-2018
Official wording
Reason: Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.
Code information: All units affected
Distribution pattern: Nationwide distribution. Worldwide foreign distribution.
Derived failure modes
-
Unknown
Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for carboxyhemoglobin (fCOHb) and methemoglobin (fMetHb). A negative interference with fCOHb has the potential to alter the medical assessment of the patient and may withhold necessary follow-up treatment and/or initiate cessation of medication in response to elevated fMetHb levels.