FDA Device

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

Hazard

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.

What You Should Do

Remedy

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 days. Customers with questions are instructed to Customer Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada, and outside US and Canada they are instructed to contact their local Beckman Coulter Representative.

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Products

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 quantitat
Brand
Beckman Coulter Inc.
UPC
M609458

Units Affected

3,158 units total (1,957 units in US)

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