Z-1341-2018 Class II Terminated
FDA device recall Z-1341-2018 was initiated by Beckman Coulter Inc. on Jan 29, 2018 and is designated Class II. Reason for recall: The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for erroneous results due to the… The recall status is terminated (terminated Jun 27, 2019). Affected quantity: 288 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Jan 29, 2018
- Termination Date
- Jun 27, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 288 devices
Product Description
Reason for Recall
Distribution Pattern
Distribution was made nationwide in the U.S. and in Puerto Rico. There was also government distribution, but no military distribution. Foreign distribution was made to Angola, Australia, Belgium, Botswana, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Kenya, Lesotho, Malawi, Malaysia, Mexico, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Uganda, Ukraine, United Kingdom, and Zambia.
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-1341-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026