FDAClass IIJuly 29, 2015

ARCHITECT c8000 System List Number 01G06-98 Product recall

ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed…

Why was ARCHITECT c8000 System List Number 01G06-98 Product recalled?

The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

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?

Serial Numbers: C802239, C802312, C802260, C802447, C801911

Product
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed…
Recalling firm
Abbott Laboratories
Quantity
5 units
Distribution
US Nationwide Distribution in the states of CA, AL, NY and WI.
Recall date
July 29, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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