FDAClass IIAugust 13, 2014

AdvanDx Quick FISH Fixation Kit for BC recall

AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold…

Why was AdvanDx Quick FISH Fixation Kit for BC recalled?

Positive result in the Internal negative control well for the Staphylococcus QuickFISH BC test, failing QC

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?

Lot Number: 04914 Exp. Date: 2015-06

Product
AdvanDx Quick FISH Fixation Kit for BC ( Blood Cultures), 50 tests. In vitro diagnostic. The QuickFISH Fixation Kits are components that are sold…
Recalling firm
Advandx Inc
Quantity
10 kits
Distribution
Distributed in the states of AZ, ID, FL, MO, OH, MI, NJ, and VA.
Recall date
August 13, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls