Product Description
ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768
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.
Action Details
On July 24, 2018 Siemens Healthineers issued Urgent Medical Device Recall notices to U.S. customers and Urgent Field Safety Notices to OUS customers.
The following are Actions to be Taken by the Customer:
Customers using ADVIA Centaur CKMB Calibrator Lots ending in 64:
- Review the notice with your Medical Director.
- Review your inventory of these products and immediately order replacement ADVIA Centaur CKMB Calibrator kit lots ending in 68 by completing the Field Correction Effectiveness Check Form attached to the letter.
- You may continue use of ADVIA Centaur CKMB Calibrator kit lots until
replacement product is received in your laboratory.
- Upon receipt of replacement product in your laboratory, discontinue use of and discard the ADVIA Centaur CKMB Calibrator kit lots listed in Table 1 of the letter.
- ADVIA Centaur CKMB Calibrator kit lots ending in 63 may continue to be used until the assigned expiration date.
- Refer to the Additional Information section for expected patient sample bias when transitioning to ADVIA Centaur CKMB Calibrator kit lots ending in 68.
Customers using ADVIA Centaur Master Curve Material:
- Discontinue use of and discard the ADVIA Centaur MCM lots in Table 1.
- Review your inventory of these products and order replacement ADVIA Centaur CKMB Master Curve Material by completing the Field Correction Effectiveness Check Form attached to the letter.
- Utilize ADVIA Centaur CKMB MCM Lot 13384 and future lots.
- Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days.
Customers using Atellica IM CKMB Calibrator Lots ending in 66:
- Review your inventory of these products and immediately order replacement Atellica IM CKMB Calibrator kit lots ending in 69 by completing the Field Correction Effectiveness Check Form attached to the letter.
- You may continue use of Atellica IM CKMB Calibrator kit lots in Table 1 until replacement product is received in your laboratory
Distribution Pattern
US Nationwide Distribution
Code Information / Serial Numbers
SMN 10309782 Lot # Expiry UDI # 35061 2019-02-10 (01)00630414056098(10)35061(17)20190210 39753 2020-06-11 (01)00630414056098(10)39753(17)20200611
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.