FDAClass IIDecember 26, 2018

Genesys Diluent Reagent recall

Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion…

Why was Genesys Diluent Reagent recalled?

lack of 510K

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?

all serial numbers

Product
Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated high performance liquid chromatography (HPLC) systems employing ion…
Recalling firm
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Quantity
463 units
Distribution
IL, WV, NJ, AZ, MD, UT
Recall date
December 26, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls