Z-2124-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 24, 2017
- Termination Date
- December 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,158 units total (1,957 units in US)
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
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.
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.
Code Information
M609458