Recall Z-1582-2013— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1582-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-16

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2013-05-16, terminated 2014-04-16. It names one FDA 510(k) clearance: K093460. Product: CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).. Reason: Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-05-16
Terminated: 2014-04-16
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093460 — COAGUCHEK XS PRO SYSTEMRoche Diagnostics·cleared 2010-03-18

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

CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).

Reason for recall

Roche has confirmed the potential for an undetected elevated INR test result with the CoaguChek XS, CoaguChek XS Plus, and CoaguChek XS Pro meters. In rare cases, instead of a value, an ERROR 6 message is displayed.

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