Z-2173-2017 Class II Terminated

Recalled by Roche Diagnostics Corporation — Indianapolis, IN

Recall Details

Product Type
Devices
Report Date
June 7, 2017
Initiation Date
April 10, 2017
Termination Date
August 4, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1603

Product Description

Elecsys PreciControl Varia 3

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

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