FDAClass IINovember 23, 2016

FlexLab Automation Modules recall

FlexLab Automation Modules

Why was it recalled?

The source record does not provide a concise hazard summary.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
FlexLab Automation Modules
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
448 units
Distribution
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
Recall date
November 23, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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