Recall Z-0116-2019— Siemens Healthcare Diagnostics, Inc

Name: FDA recall Z-0116-2019
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: Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.. 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

Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.

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.