ModerateClass IITerminated

FDA Devices recall · Reported May 16, 2018

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 16, 2018. Severity: Moderate. Recall number: Z-1643-2018.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey.

Q: 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.

Q: 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.

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 o…

Recall #: Z-1643-2018
Affected scope: 2225 units
Initiated: March 2, 2018

Compiled from official public sources by the editorial team. · Updated July 2026

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Beckman Coulter Inc. recalled BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-71… - a moderate-severity action.

BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-71… was recalled by Beckman Coulter Inc. in May 16, 2018. Reason: Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North Amer…. Check the official notice for the remedy. Verify recall #Z-1643-2018 with the FDA Devices before acting.

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The recall

Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North Amer….

Moderate
severity level: 2K units
affected scope: Class II
classification: May 16, 2018
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1643-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

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 list the affected scope as 2225 units.

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.

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.

Where this recall sits in the database

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.

Severity

Moderate

Affected scope

2225 units

Related Recalls

3 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.

Recall Profile

Structured summary of the FDA Devices recall record
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.
Firm location	Brea, CA
Affected scope	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.

Scale of Impact

2225 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1643-2018) 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? ▼

Why was this product recalled? ▼

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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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 May 16, 2018. 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.