Z-2157-2017 Class II Terminated
FDA device recall Z-2157-2017 was initiated by Beckman Coulter Inc. on April 24, 2017 and is designated Class II. Reason for recall: There is a possibility of a data acquisition disruption that may cause an unusual light scatter event pattern for the white blood cell differential that may not have a system flag and/or message. The … The recall status is terminated (terminated May 22, 2018). Affected quantity: 4880 units total (2119 units in US).
Recall Details
- Product Type
- Devices
- Report Date
- May 31, 2017
- Initiation Date
- April 24, 2017
- Termination Date
- May 22, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4880 units total (2119 units in US)
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution: US nationwide, Algeria, Andorra, Austria, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Cote d'lvoire, Croatia, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan , Kuwait, Lebanon, Lithuania ,Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania , Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia , South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Republic, United Kingdom, Uruguay and Vietnam.