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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750

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 Class 2 Device Recall Siemens RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750see related information
Date Initiated by FirmOctober 26, 2023
Date PostedDecember 21, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0609-2024
Recall Event ID 93473
510(K)NumberK122398 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductRAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
Code Information UDI-DI: 00630414589770 All serial numbers
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics Inc
2 Edgewater Dr
Norwood MA 02062-4637
For Additional Information ContactSAME
781-269-3000
Manufacturer Reason
for Recall		RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of hypernatremia or unnecessary intervention for hyponatremia and result in iatrogenic hypernatremia especially if the true sodium result is near the thresholds of severe alterations, as well as cause a Question Result -----? error flag for multiple electrolytes on patient samples and quality control that may cause a delay of diagnosis or treatment.
FDA Determined
Cause 2		Under Investigation by firm
ActionSiemens Healthineers issued Urgent Medical Device Correction POC 24-004.A.US on November 1, 2023 to US customers. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. If you experience this issue, you may request a no-charge replacement or receive a credit from your local Siemens Healthineers representative. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. Siemens Healthineers is conducting a comprehensive evaluation with a cross-functional team to promptly resolve the issue with utmost priority. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Health Products Regulatory Authority (HPRA) has been notified by the Siemens Authorized Representative in Ireland. Local representatives for EU and non-EU regions have also been notified of this Urgent Field Safety Notice (OUS Version) and will follow local requirements for contacting their respective National Competent Authorities to advise them of the issue.
Quantity in Commerce3505 Cartridges US
DistributionNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Cambodia Canada Chile China Colombia Congo, Republic Costa Rica C¿te dIvoire Croatia Cura¿ao Czech Republic Denmark Ecuador Egypt Estonia Fiji Finland France French Polynesia Georgia Germany Ghana Greece Guadeloupe Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kosovo Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia, former Yugoslav Rep. of Malaysia Maldives Mali Martinique Mexico Moldova, Rep. of Montenegro Namibia Nepal Netherlands New Caledonia New Zealand Norway Oman Pakistan Palestinian Territory, Occupied Paraguay Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Federation Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan, Province of China Thailand Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom Great Britain United Republic of Tanzania Uruguay Uzbekistan Vietnam
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JIX
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