FDA Enforcement
Class II
Terminated
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.
Recall: Z-0117-2019
·
Reported October 24, 2018
Enforcement
- Recall Number
- Z-0117-2019
- Event ID
- 80954
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 24, 2018
- Initiation Date
- July 24, 2018
- Classification Date
- October 15, 2018
- Termination Date
- May 26, 2020
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
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
A potential bias was identified with certain kits compared to the internal standards.
Code Info
SMN 10995534 Lot # Expiry UDI # 11803 2019-02-10 (01)00630414598611(10)11803(17)20190210
Distribution
US Nationwide Distribution
Quantity
2 sets