FDAClass IIJune 7, 2017

Elecsys PreciControl Varia 3 recall

Elecsys PreciControl Varia 3

Why was Elecsys PreciControl Varia 3 recalled?

e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays

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 Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160

Product
Elecsys PreciControl Varia 3
Recalling firm
Roche Diagnostics Corporation
Quantity
1603
Distribution
Nationwide
Recall date
June 7, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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