The Recall Desk
HighFDA (Devices)·Z-2087-2016·Announced 2016-07-06

Siemens Hettich Centrifuge Modules Recalled for Premature Bucket Failures

Siemens Healthcare Diagnostics Inc. is recalling 487 Hettich Centrifuge Modules due to premature bucket failures. The units were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a mechanical failure (premature bucket failure) in a medical device that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Siemens Healthcare Diagnostics Inc. is recalling 487 Hettich Centrifuge Modules, including StreamLAB, Aptio, and FlexLab models, due to premature bucket failures. These modules are used to separate substances according to their densities. The recall covers all serial numbers for the affected models.

The affected units were distributed nationwide to facilities in 35 states, including Alabama, Arizona, California, Florida, Illinois, New York, and Texas. The specific hazard identified is the premature failure of the centrifuge buckets.

Healthcare facilities should stop using the affected centrifuge modules and contact Siemens Healthcare Diagnostics Inc. for further instructions on the recall.

The recalled product

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 substanc
Affected units
487

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers are affected.

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

Same manufacturer · Siemens Healthcare Diagnostics Inc.

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