Device product

Elecsys PreciControl Varia 3

Z-2173-2017

April 10, 2017

Class II

Product summary

Firm: Roche Diagnostics Corporation
Event: Event 77108
Status: Terminated
Classification: Class II
Quantity: 1603
Official record key: device-enforcement:Z-2173-2017

Official wording

Reason: 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

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

Distribution pattern: Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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