Severity
Moderate
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well a
Reported: May 16, 2018 Initiated: March 2, 2018 #Z-1643-2018 2225 units units
Beckman Coulter Inc. issued this FDA Devices recall on May 16, 2018. Classified as Moderate severity (Class II). Approximately 2225 units units are affected. The recall was issued because: Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChem…. 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-1643-2018) was formally reported on May 16, 2018, with the manufacturer initiating the action on March 2, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Beckman Coulter Inc. is listed as the recalling firm, operating out of Brea, CA. Federal records indicate 2225 units units are affected.
The documented reason for this recall is: Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in t… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey. 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 8 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
2225 units
Related Recalls
6
6 from same agency
Product Description
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
Reason for Recall
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
Details
- Recalling Firm
- Beckman Coulter Inc.
- Units Affected
- 2225 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey
- Location
- Brea, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1643-2018 |
| Date reported | May 16, 2018 |
| Date initiated | March 2, 2018 |
| Recalling firm | Beckman Coulter Inc. |
| Units affected | 2225 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey |
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? ▼
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-3079, 800-3080, 800-7190, 800-7713, 800-7714, 800-7715, 700- 7176-001, 700-7177-001 Product Usage: The iChemVELOCITY automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. The iChemVELOCITY can be used as a stand-alone system, as well as in an iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi- quantitative results for glucose, blood, leukocyte esterade, bilirubin, urobilinogen, pH, protein, ketones, and ascorbic acid; and qualitative results for nitrites, color, and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer. The measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver finction. Tests performed using the iChemVELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.. Recalled by Beckman Coulter Inc.. Units affected: 2225 units.
Why was this product recalled? ▼
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1643-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1643-2018) 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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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).