Z-2087-2016Class II

Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge...

Name: Z-2087-2016 Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge...
Creator: Siemens Healthcare Diagnostics Inc.
Published: 2016-05-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-05-11 / Terminated

FDA source

Siemens Healthcare Diagnostics Inc. began a recall of Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Centrifuge Module (10703032 or 10713761) FlexLab High... on 2016-05-11. FDA classified it as Class II and gives the reason as "Premature bucket failures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2087-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-11
Posted: 2016-06-29
Terminated: 2018-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Reason for recall: Premature bucket failures
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 487
Distribution: 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.
Product codes and lots: All serial numbers are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2087-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2087-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-29

Product code LXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)