FDAClass IINovember 25, 2020

cobas infinity central lab/cobas infinity core recall

cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and…

Why was cobas infinity central lab/cobas infinity core recalled?

Potential Incorrect Validation of Results Due to an Erroneous QC Status When Using Status Expiration Control Rule

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?

Software versions from cobas infinity version 3.00.00 onwards Serial Numbers: 82014 82229 82028 82227 82066 81967 81946 82121 82027 82194 82120 81528 82231 81958 82246 81983 82118 82165 81886 82082 82256 82257 81781 82331 82304 82087 82276 81465 81959 82235 82180 82181 82236 81945 82275 81662 82065 82253 81817 82000

Product
cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and…
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
40 licenses
Distribution
Nationwide
Recall date
November 25, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls