FDAClass IIMay 9, 2018

cobas b 221 AutoQC Module Complete recall: Software Issue

cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…

Why was cobas b 221 AutoQC Module Complete recalled?

The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.

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: 3313522001 and 3313522692

Product
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical…
Recalling firm
Roche Diagnostics Corporation
Quantity
1026 total products
Distribution
USA ( nationwide)
Recall date
May 9, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls