Recall Z-2124-2017 ยท DCF Albumin, Antigen, Antiserum, Control
Beckman Coulter Inc.
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
| Date | Apr 24, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | Beckman Coulter sent an Urgent Medical Device Recall letter dated April 24, 2017, to affected customers to inform them that 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. Internal testing has confirmed that MA is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2. Customers are informed of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed response form within 10 |
| Quantity | 3,158 units total (1,957 units in US) |
| Distribution | 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, Switzer |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082251 | SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 Beckman Coulter, Inc., Apr 8, 2009 |