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Beckman Coulter Inc. recalls Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to ca
Recalled November 23, 2016 · FDA recall Z-0407-2017 · Beckman Coulter
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. · FDA Class II
Units
357 kits total (94 kits in US)
Sold at
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.
Description
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.
Product
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
Manufacturer(s)
Beckman Coulter Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →