Recall Z-0114-2019— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0114-2019
Creator: U.S. Food and Drug Administration
Published: 2018-07-24

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2018-07-24, terminated 2020-05-26. It names one FDA 510(k) clearance: K962126. Product: ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.. Reason: A potential bias was identified with certain kits compared to the internal standards..

Recalling firm: Siemens Healthcare Diagnostics, Inc
Classification: Class II
Status: Terminated
Initiated: 2018-07-24
Terminated: 2020-05-26
Firm location: East Walpole, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K962126 — ACS CKMB II IMMUNOASSAYCiba Corning Diagnostics Corp.·cleared 1996-06-21

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

ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.

Reason for recall

A potential bias was identified with certain kits compared to the internal standards.

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