Recall Z-0407-2017 ยท JIS Calibrator, Primary
Beckman Coulter Inc.
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.
| Date | Oct 24, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated October 24, 2016 was sent to all their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding the notice are instructed to contact Customer Technical Support Center at http://www.beckmancoulter.com, (800) 854-3633 in US and Canada, and to contact local Beckman Coulter representative if outside of US and Canada. |
| Quantity | 357 kits total (94 kits in US) |
| Distribution | 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, R |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc., Mar 28, 2000 |