Recalls / —
—#147052
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.
- FDA product code
- LXG — Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- All serial numbers are affected.
Why it was recalled
Premature bucket failures
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
Siemens mailed to customers an Urgent Medical Device Correction (UMDC#LAI16-02.A.US) Urgent Field Safety Notification letter informing customers of the problem with recommendations to follow the existing maintenance instructions in the product operator manuals as well as a new requirement to spin at cycle speeds not exceeding 3500 rpm.
Recalling firm
- Firm
- Siemens Healthcare Diagnostics Inc.
- Address
- 101 Silvermine Rd, Brookfield, Connecticut 06804-2047
Distribution
- 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.
Timeline
- Recall initiated
- 2016-05-11
- Terminated
- 2018-04-27
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #147052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.