CLASS II ONGOING Device recall · Reported 27 Dec 2023 · FDA Enforcement Report

RAPIDPoint 500 Systems Measurement Cartridge recalled

Siemens Healthcare Diagnostics is recalling RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro, distributed nationwide in the US. The recall was initiated on 26 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 00630414947556 All serial numbers

Quantity recalled0 cartridges US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0606-2024
FDA event ID: 93473
Recalling firm: Siemens Healthcare Diagnostics, Norwood, MA
Classification: Class II
Status: Ongoing
Recall initiated: 26 Oct 2023
FDA classified: 21 Dec 2023
Reported: 27 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Test Kits & Diagnostics

Timeline

26 Oct 2023	Recall initiated by company
21 Dec 2023	Classified by FDA	+56 days
27 Dec 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

Nationwide 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

Nationwide Georgia

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI: 00630414947556 All serial numbers

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 93473

This product is part of a recall event; the main page for the event is RAPIDPoint 500 Systems Measurement Cartridge recalled.

Reported	Class	Recall	Company	Reason	Where
27 Dec 2023	CLASS II	RAPIDPoint 500 Systems Measurement Cartridge recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
27 Dec 2023	CLASS II	RAPIDPoint 500 Systems Measurement Cartridge recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide
27 Dec 2023	CLASS II	RAPIDPoint 500 Systems Measurement Cartridge recalled	Siemens Healthcare Diagnostics	Device Malfunction	Nationwide

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