Z-1169-2018 Class II
FDA device recall Z-1169-2018 was initiated by Beckman Coulter Inc. on Jan 19, 2018 and is designated Class II. Reason for recall: Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination. Affected quantity: 98 units in the US.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Jan 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98 units in the US
Product Description
Reason for Recall
Distribution Pattern
Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Macao, Mayotte, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1169-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026