Recall Z-2173-2017— Roche Diagnostics Corporation

Name: FDA recall Z-2173-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-10

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Corporation, initiated 2017-04-10, terminated 2017-08-04. It names one FDA 510(k) clearance: K111506. Product: Elecsys PreciControl Varia 3. 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.

Recalling firm: Roche Diagnostics Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-04-10
Terminated: 2017-08-04
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K111506 — ELECSYS PRECICONTROL VARIA 3Roche Diagnostics·cleared 2011-07-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.