Z-0117-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2018
- Initiation Date
- July 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