Beckman Coulter Inc.: Medical Device Recall in 2016 - (Recall #: Z-0407-2017)

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 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.

Product Classification:

Class II

Date Initiated: October 24, 2016

Date Posted: November 23, 2016

Recall Number: Z-0407-2017

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: 357 kits total (94 kits in US)

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.

Voluntary or Mandated:

Voluntary: Firm initiated