Z-0117-2019 Class II Terminated
FDA device recall Z-0117-2019 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: 2 sets.
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
- 2 sets
Product Description
Atellica IM CKMB Master Curve Material, Cat No. 10995534 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.
Distribution Pattern
US Nationwide Distribution
Code Information
SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0117-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026