CLASS II Device recall · Reported 30 May 2018 · FDA Enforcement Report
iChem Velocity Automated Urine Chemistry System recalled
Beckman Coulter is recalling iChem Velocity Automated Urine Chemistry System, distributed in Alabama, Florida, Georgia, Iowa. The recall was initiated on 29 Mar 2018 and the FDA has classified it as Class II.
Check your package
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-1894-2018
- FDA event ID
- 79895
- Recalling firm
- Beckman Coulter, Brea, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Mar 2018
- FDA classified
- 18 May 2018
- Reported
- 30 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 29 Mar 2018 | Recall initiated by company | |
| 18 May 2018 | Classified by FDA | +50 days |
| 30 May 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. 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 a iQ200 Series system, a configuration given the proprietary name iRICELL as it is designed to be hardware and software compatible with iQ200 Series systems.
Where it was distributed
US Distribution to states of: AL, IA, GA, and FL.
Questions about this recall
Why was it recalled?
The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.
Which lots are affected?
Catalog 700-7176-001 - Serial numbers V04494 and CV04015; Catalog 700-7177-001 - Serial numbers CV04012, CV04013, CV04014, and CV04017.
Where was it sold?
US Distribution to states of: AL, IA, GA, and FL.
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.
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