Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-0408-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase QC is intended for monitoring system performance of the Access Ostase assay.

Product Classification:

Class II

Date Initiated: October 24, 2016

Date Posted: November 23, 2016

Recall Number: Z-0408-2017

Event ID: 75526

Reason for Recall:

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.

Status: Terminated

Product Quantity: 625 kits total (113 kits in US)

Code Information:

628297 623207 626001

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.

Voluntary or Mandated:

Voluntary: Firm initiated