Beckman Coulter Inc.: Medical Device Recall in 2017 - (Recall #: Z-2124-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON¿ Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine

Product Classification:

Class II

Date Initiated: April 24, 2017

Date Posted: May 31, 2017

Recall Number: Z-2124-2017

Event ID: 77138

Reason for Recall:

Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.

Status: Terminated

Product Quantity: 3,158 units total (1,957 units in US)

Code Information:

M609458

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated