FDAClass IINovember 29, 2017

Tubing recall

Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.

Why was Tubing recalled?

The Peristaltic Head tubing placed on the ARCHITECT c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.

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 - 125589-1-2, 125589-1-4

Product
Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
Recalling firm
Abbott Laboratories, Inc
Quantity
44 units
Distribution
Worldwide distribution to US, Canada, France, and Germany.
Recall date
November 29, 2017
Classification
Class II
Status
Completed
Agency
FDA (device)
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