Recall Z-0408-2017 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Beckman Coulter Inc.
Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
| 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 | 625 kits total (113 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 |