Recall Z-2124-2017
Beckman Coulter Inc. · initiated April 24, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: M609458
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.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2124-2017
- Initiated
- April 24, 2017
- Terminated
- December 30, 2017
- Product code
- DCF – Albumin, Antigen, Antiserum, Control
- 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, Switzerland, Taiwan, and United Kingdom.
- Recalling firm
- Beckman Coulter Inc., Brea, CA