Roche Diagnostics Corporation: Medical Device Recall in 2017 - (Recall #: Z-2173-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Elecsys PreciControl Varia 3

Product Classification:

Class II

Date Initiated: April 10, 2017

Date Posted: June 7, 2017

Recall Number: Z-2173-2017

Event ID: 77108

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

Status: Terminated

Product Quantity: 1603

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated