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U.S. Department of Health and Human Services

Class 2 Device Recall RAPIDLab 1265 System

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  Class 2 Device Recall RAPIDLab 1265 System see related information
Date Initiated by Firm July 16, 2018
Create Date August 24, 2018
Recall Status1 Terminated 3 on June 23, 2020
Recall Number Z-2930-2018
Recall Event ID 80516
510(K)Number K031560  
Product Classification System, hemoglobin, automated - Product Code GKR
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.
Code Information All units affected
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
Po Box 6101
Newark DE 19702-2466
For Additional Information Contact
800-441-9250
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 2357
Distribution Nationwide distribution. Worldwide foreign distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKR and Original Applicant = BAYER HEALTHCARE, LLC
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