Device product
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.
Z-0117-2019
Product summary
- Event
- Event 80954
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 sets
- Official record key
device-enforcement:Z-0117-2019
Official wording
Reason: A potential bias was identified with certain kits compared to the internal standards.
Code information: SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
A potential bias was identified with certain kits compared to the internal standards.