FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0408-2017
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.
- Status
- Terminated
- Initiated
- 2016-10-24
- Posted
- not on file
- Terminated
- 2018-02-01
- 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, Russian Federation, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan.
- Lot, serial or model codes
- 628297 623207 626001
- 510(k) numbers
- ["K994278"]
- PMA numbers
- not on file
- Product code
- JJX
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28