—#165657

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.

FDA product code: GKR — System, Hemoglobin, Automated
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K031560
Affected lot / code info: All units affected

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Po Box 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: Nationwide distribution. Worldwide foreign distribution.

Timeline

Recall initiated: 2018-07-16
Terminated: 2020-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165657. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.