Atellica IM CKMB Calibrator, Cat No. 10995532 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.
Reported: October 24, 2018 Initiated: July 24, 2018 #Z-0116-2019
Product Description
Atellica IM CKMB Calibrator, Cat No. 10995532 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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 97 kits
- Distribution
- US Nationwide Distribution
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Atellica IM CKMB Calibrator, Cat No. 10995532 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.. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 97 kits.
Why was this product recalled? ▼
A potential bias was identified with certain kits compared to the internal standards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 24, 2018. Severity: Moderate. Recall number: Z-0116-2019.
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