FDA-Device2016-11-23Class II
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Beckman Coulter Inc.
Hazard
Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
Sold states
US Nationwide Distribution in the states of: UT, MI, MA, LA, IN, NC, CA, TX, NJ, IL, WI, MN, FL, KA, NY, CO, WA, KY, VA, and AL. Affected geographies: Belgium, Canada, China, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Mexico, Philippines, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.
Affected count
625 kits total (113 kits in US)
Manufactured in
250 S Kraemer Blvd, N/A, Brea, CA, United States
Products
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2017Don't want to check this manually?
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