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Recall Observatory FDA recall evidence

Device 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.

Z-2087-2016

May 11, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics Inc.
Event
Event 74280
Status
Terminated
Classification
Class II
Quantity
487
Official record key
device-enforcement:Z-2087-2016

Official wording

Reason: Premature bucket failures

Code information: All serial numbers are affected.

Distribution pattern: Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Premature bucket failures