Severity
Moderate
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813
Reported: July 30, 2014 Initiated: May 23, 2014 #Z-2079-2014 20,507 cartridges units
Siemens Healthcare Diagnostics Inc issued this FDA Devices recall on July 30, 2014. Classified as Moderate severity (Class II). Approximately 20,507 cartridges units are affected. The recall was issued because: RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-2079-2014) was formally reported on July 30, 2014, with the manufacturer initiating the action on May 23, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics Inc is listed as the recalling firm, operating out of Norwood, MA. Federal records indicate 20,507 cartridges units are affected.
The documented reason for this recall is: RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) Distribution data in the federal record shows the product reached: Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
20,507 cartridges
Related Recalls
6
6 from same agency
Product Description
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813
Reason for Recall
RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
Details
- Recalling Firm
- Siemens Healthcare Diagnostics Inc
- Units Affected
- 20,507 cartridges
- Distribution
- Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan
- Location
- Norwood, MA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2079-2014 |
| Date reported | July 30, 2014 |
| Date initiated | May 23, 2014 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Units affected | 20,507 cartridges |
| Distribution | Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France Un… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 20,507 cartridges.
Why was this product recalled? ▼
RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2079-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: U.A.E. Albania Austria Australia Bosnia Herzeg. Belgium Bulgaria Bahrain Brazil Canada Switzerland P.R. China Colombia Czech Republic Germany Denmark Algeria Estonia Egypt Spain Finland France United Kingdom Georgia Greece Hong Kong Croatia Hungary Indonesia Ireland Israel India Italy Japan Republic Korea Kuwait Lithuania Luxembourg Latvia Malaysia Mexico Netherlands Norway New Zealand Peru Poland Portugal Qatar Romania Serbia Russian Fed. Saudi Arabia Sweden Singapore Slovenia Turkey Taiwan.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2079-2014) 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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Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).