RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to

FDA device recall Z-0608-2024 · posted 2023-12-21 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

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.

Action taken

Siemens 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JIX

Quantity affected

6611 cartridges US

Distribution

Nationwide with Worldwide Distribution to: Albania Algeria Angola Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belarus Belgium Bolivia Bosnia and Herzegovina Botswana Brazil Brune

Date initiated

2023-10-26

Date posted

2023-12-21

Location

Norwood, MA

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