FDAClass IISeptember 11, 2019

cobas e 601 module recall

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001

Why was cobas e 601 module recalled?

Quality issue with high pressure solenoid valves may cause inaccurate results.

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 # : 31A1-01

Product
cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
1 unit
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