medical Class II Updated 2019-12-04

Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer

Recalled Product

Atellica CH 930 Analyzer


Hazard / Issue

Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

Issued by

FDA

Affected States: AL, AZ, AR, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MA, MI, MN, MS, NE, NV, NH, NJ, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, WA, WV, DC, DE
Lot/Code Info: SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163
View official government recall

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