Z-0113-2019 Class II Terminated
FDA device recall Z-0113-2019 was initiated by Siemens Healthcare Diagnostics, Inc on Jul 24, 2018 and is designated Class II. Reason for recall: A potential bias was identified with certain kits compared to the internal standards. The recall status is terminated (terminated May 26, 2020). Affected quantity: 1870 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2018
- Initiation Date
- Jul 24, 2018
- Termination Date
- May 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1870 kits
Product Description
ADVIA Centaur CKMB Calibrator, Cat No. 09318028 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.
Distribution Pattern
US Nationwide Distribution
Code Information
SMN 10311570 Lot # Expiry UDI # 57834A64 2018-Dec-11 (01)00630414124803(10)57834A64(17)20181211 57835A64 2018-Dec-11 (01)00630414124803(10)57835A64(17)20181211 72519A64 2018-Dec-11 (01)00630414124803(10)72519A64(17)20181211 98115A64 2018-Dec-11 (01)00630414124803(10)98115A64(17)20181211
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0113-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026