FDAClass IIApril 24, 2019

syngo Lab Data Manager System - Product Usage: syngo recall: Software Issue

syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with…

Why was syngo Lab Data Manager System - Product Usage: syngo recalled?

Software Issues.

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?

Catalog Numbers: 10638933, 10624077, 10804573 510K Exempt

Product
syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assists medical laboratory professions with…
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
449 systems
Distribution
Worldwide distribution - US Nationwide and countries of Japan, Germany, Belgium, France, Italy, Slovakia, Bahamas, United Kingdom and Mexico.
Recall date
April 24, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls