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Siemens Healthcare Diagnostics, Inc recalls Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA
Recalled October 24, 2018 · FDA recall Z-0116-2019 · Siemens Healthcare Diagnostics
Hazard
A potential bias was identified with certain kits compared to the internal standards. · FDA Class II
Units
97 kits
Sold at
US Nationwide Distribution
Description
A potential bias was identified with certain kits compared to the internal standards.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →