Z-2124-2017 Class II Terminated
FDA device recall Z-2124-2017 was initiated by Beckman Coulter Inc. on April 24, 2017 and is designated Class II. 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. The recall status is terminated (terminated December 30, 2017). Affected quantity: 3,158 units total (1,957 units in US).
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
Reason for Recall
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.