FDAClass IINovember 4, 2015

Sentinel MULTIGENT Ammonia Ultra Reagent recall

Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative…

Why was Sentinel MULTIGENT Ammonia Ultra Reagent recalled?

Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

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 50083Y600, expiration date 31 Jul 2016.

Product
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative…
Recalling firm
Sentinel CH SpA
Quantity
765 kits
Distribution
Nationwide Distribution.
Recall date
November 4, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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