FDAClass IIApril 2, 2014

AMS URIC ACID For the In vitro quantitative recall

AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.

Why was AMS URIC ACID For the In vitro quantitative recalled?

Marketing the devices outside 510(k) requirements

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?

Model Numbers: 40147, 80147. Lot codes: 131253, 131254, 131255.

Product
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Recalling firm
AMS Diagnostics, LLC
Quantity
13 kits
Distribution
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Recall date
April 2, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls