Device 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.
Z-0407-2017
Product summary
- Event
- Event 75526
- Status
- Terminated
- Classification
- Class II
- Quantity
- 357 kits total (94 kits in US)
- Official record key
device-enforcement:Z-0407-2017
Official wording
Reason: 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.
Code information: 623207 626000 628294 628296
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.