Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 27, 2023
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics Inc recalled RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro dia… - a moderate-severity action.
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro dia… was recalled by Siemens Healthcare Diagnostics Inc in December 27, 2023. Reason: RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sen…. Check the official notice for the remedy. Verify recall #Z-0608-2024 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics Inc issued this moderate-severity FDA Devices recall-RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sen….
- Moderate
- severity level
- Class II
- classification
- December 27, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0608-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0608-2024) was formally reported on December 27, 2023, with the manufacturer initiating the action on October 26, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics Inc is listed as the recalling firm, operating out of Norwood, MA. Federal records list the affected scope as 6611 cartridges US.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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 Bulga…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6611 cartridges US
Related Recalls
6
3 from same agency
Product description
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0608-2024 |
| Date reported | December 27, 2023 |
| Date initiated | October 26, 2023 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Firm location | Norwood, MA |
| Affected scope | 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 Brunei Darussalam Bulgaria Burkina Faso Cam… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0608-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491448. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 6611 cartridges US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 27, 2023. Severity: Moderate. Recall number: Z-0608-2024.
Where was the recalled product distributed? ▼
Distribution: 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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0608-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 27, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.