Z-3135-2017 Class II Terminated
FDA device recall Z-3135-2017 was initiated by Beckman Coulter Inc. on August 21, 2017 and is designated Class II. Reason for recall: Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a … The recall status is terminated (terminated September 27, 2023). Affected quantity: 213 units (34 units in the US).
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2017
- Initiation Date
- August 21, 2017
- Termination Date
- September 27, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 213 units (34 units in the US)
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution: United States (nationwide) and countries of: Angola, Australia, Botswana, Canada, Chile, Columbia, Ghana, Israel, Malaysia, Namibia, Pakistan, Panama, South Africa, Uganda, France, Switzerland, Poland, Portugal, Germany, Belgium, Finland, Czech Republic, Denmark, Netherland, Turkey, Spain, Great Britain, Romania, Brazil, Italy, Sweden, Ghana, Colombia, Lesotho and Zambia