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Recall Observatory FDA recall evidence

Device product

FlexLab Automation Modules

Z-0591-2017

September 29, 2016

Class II

Product summary

Firm
Siemens Healthcare Diagnostics, Inc.
Event
Event 75417
Status
Terminated
Classification
Class II
Quantity
448 units
Official record key
device-enforcement:Z-0591-2017

Official wording

Reason: Unavailable

Code information: Refrigerated Storage Module (RSM): 11171750. Centrifuge (CM): 11171747. i2000SR (i2000SR): 11171801.

Distribution pattern: Distributed Nationwide and to the following countries: Australia, Azerbaijan, Bahrain, Bangladesh, Belgium, Brazil, Canada, Czech Republic, Denmark, Egypt, Germany, Greece, Indonesia, Italy, Kingdom Saudi Arabia, Lebanon, Malaysia, P.R. China, Philippines, Portugal, Qatar, Republic Korea, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam