Recall Z-0606-2024— Siemens Healthcare Diagnostics Inc

Name: FDA recall Z-0606-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-26

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc, initiated 2023-10-26. It names one FDA 510(k) clearance: K122398. Product: RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-10-26
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122398 — RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare Diagnostics, Inc.·cleared 2012-10-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.