CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

iChem Velocity Automated Urine Chemistry recalled by Beckman Coulter

Beckman Coulter is recalling iChem Velocity Automated Urine Chemistry, distributed in Puerto Rico. The recall was initiated on 13 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall serial numbers

Quantity recalled2,661 units total (1,424 units in US)

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-1067-2016
FDA event ID: 73100
Recalling firm: Beckman Coulter, Brea, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jan 2016
FDA classified: 7 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

13 Jan 2016	Recall initiated by company
7 Mar 2016	Classified by FDA	+54 days
16 Mar 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.

Product as listed by the FDA

iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001

Where it was distributed

Affected geographies: Argentina, Australia, Austria, Bangladesh, Bermuda, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Canada, Chile, China, Columbia, Croatia, Czech Republic, Ecuador, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Republic of Korea, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mexico, Montenegro, Netherlands, New Zealand, Nigeria, Oman, Panama Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico , Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Republic, United States (including Puerto Rico), and Venezuela

Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

all serial numbers

Where was it sold?

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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