Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
Recall Number
Z-1484-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-01-20
Reported
2026-03-11
Distribution
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Chile, Curacao,¿St¿Eus, Czech¿Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Korea, Latvia, Malaysia, Netherlands, New Zealand, Norway, Portugal, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United¿Kingdom.
Code Info
Material Number: 11537225. UDI-DI: 00630414611099. Lot Numbers: All lot numbers.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.