FDAClass IIJune 23, 2021

WorkMate Claris v.1.2 Upgrade Kits recall: Software Issue

WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012

Why was WorkMate Claris v.1.2 Upgrade Kits recalled?

Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

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?

None

Product
WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012
Recalling firm
Abbott Laboratories Inc. (St Jude Medical)
Quantity
8 units
Distribution
US Nationwide distribution in the states of MI, KS, MO, TX.
Recall date
June 23, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls