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.
- Recall Initiated
- July 16, 2018
- Terminated
- June 23, 2020
- Recall Number
- Z-2930-2018
- Quantity
- 2357
- Firm Location
- Newark, DE
Reason for Recall
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.
Distribution
Nationwide distribution. Worldwide foreign distribution.
Lot / Code Info
All units affected
Root Cause
Device Design
Action Taken
The firm, Siemens Healthineers, sent an "Urgent Field Safety Notice" letter dated 7/2018 to its customers via FedEx on 7/18/18. The recall communication alerts customers that therapeutic levels of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas Systems identified in the letter. Customer are advised to review the letter with their Medical Director, and complete and return the effectiveness check form within 7 days. Customers may continue to use their devices. Siemens is not recommending a review of previously generated results. The firm stated that they will be revising the Operators Guides for the 500 and 1200 series Operator's Guides with information on the interfering substance. The RapidPoint 405 Operator's Guide will not be revised due to the discontinuation of the manufacture of this analyzer. However, users should remain aware of the issue with hydroxocobalamine interference. Customers with questions were directed to contact their local Siemens technical support representative or Safety Officer (POC) at 800-441-9250 or email to: steven.andberg@siemens-healthineers.com.