FDAClass IINovember 13, 2013

Emit 2000 Phenobarbital Assay and Syva Emit 2000 recall

Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

Why was Emit 2000 Phenobarbital Assay and Syva Emit 2000 recalled?

Imprecision with certain lots

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?

Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.

Product
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
4963
Distribution
Worldwide Distribution - USA (nationwide) and Mexico.
Recall date
November 13, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls