medical Class II Updated 2018-10-24

Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748

Recalled Product

ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic use in calibrating ADVIA Centaur systems CKMB assays.


Hazard / Issue

A potential bias was identified with certain kits compared to the internal standards.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: SMN 10333512 Lot # Expiry UDI # 58311A67 2018-Dec-11 (01)00630414056890(10)58311A67(17)20181211 97468A67 2018-Dec-11 (01)00630414056890(10)97468A67(17)20181211
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