Recall Z-2087-2016— Siemens Healthcare Diagnostics Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics Inc., initiated 2016-05-11, terminated 2018-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.. Reason: Premature bucket failures.
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-11
- Terminated
- 2018-04-27
- Firm location
- Brookfield, CT, United States
Product description
Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High Throughput Centrifuge Module (11171747) FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
Reason for recall
Premature bucket failures
Data sourced from openFDA. This site is unofficial and independent of the FDA.