FDAClass IIIJanuary 4, 2017

Urea Nitrogen/Color BUN recall

Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a…

Why was Urea Nitrogen/Color BUN recalled?

Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

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?

Urea Nitrogen/Color BUN, CAT No. 2290-L , Lot No. 29051, Expriry: 9/18, Manufactured: 09/21/15

Product
Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a…
Recalling firm
Sterling Diagnostics, Inc.
Quantity
131
Distribution
Domestic: MI Foreign: Phillipines VA/DOD: None
Recall date
January 4, 2017
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls