FDAClass IIApril 4, 2018

Modular E 170 Analyzer: Immunoassay Chemistry Analyzer recall

Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001…

Why was Modular E 170 Analyzer: Immunoassay Chemistry Analyzer recalled?

Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters.

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
Modular E 170 Analyzer: Immunoassay Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use, Catalog Numbers: 03739040692, 03023109001…
Recalling firm
Roche Diagnostics Corporation
Distribution
US Nationwide
Recall date
April 4, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls