Recall Z-1925-2013— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-06-05, terminated 2015-03-18. It names one FDA 510(k) clearance: K970336. Product: Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.. Reason: Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-06-05
- Terminated
- 2015-03-18
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with heterogeneous immunoassay module.
Reason for recall
Siemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs, gel-like clumps may be observed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.