—#143067

Product

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

FDA product code: KQO — Automated Urinalysis System
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K101852
Affected lot / code info: all serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Iris sent an Urgent Medical Device Recall letter dated January 13, 2016 and an updated notification letter dated February 19, 2016 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form within 10 days. Customers with questions or concerns are instructed to contact their local support representative: Via our website, at http://www.beckmancoulter.com By phone, call 800 854-3633 in the United States and Canada.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2016-01-13
Terminated: 2016-08-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143067. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.