Z-1151-2018 Class II Terminated
FDA device recall Z-1151-2018 was initiated by Beckman Coulter Inc. on Jan 18, 2018 and is designated Class II. Reason for recall: A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples without pipette tips. The recall status is terminated (terminated Sep 27, 2023). Affected quantity: 73 units in US.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 28, 2018
- Initiation Date
- Jan 18, 2018
- Termination Date
- Sep 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 units in US
Product Description
Reason for Recall
Distribution Pattern
Worldwide distribution. US nationwide, Algeria, 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, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russia, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
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-1151-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026