FDAClass IISeptember 5, 2012

Sunquest Laboratory Versions 6.4 and later using recall

Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

Why was Sunquest Laboratory Versions 6.4 and later using recalled?

The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.

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?

Versions 6.4 and later

Product
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Recalling firm
Sunquest Information Systems, Inc.
Quantity
127 sites
Distribution
Worldwide Distribution -- USA (nationwide) and the country of Canada.
Recall date
September 5, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls