FDAClass IISeptember 11, 2019

cobas c513 Analyzer recall

cobas c513 Analyzer

Why was cobas c513 Analyzer recalled?

Quality issue with high pressure solenoid valves

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?

Serial # :1731-08, 1722-03

Product
cobas c513 Analyzer
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
2 units
Distribution
State NY MT HI IN MD TX OH KS KY CA FL OR LA MO AK
Recall date
September 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls