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Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer
Recalled December 4, 2019 · FDA recall Z-0581-2020 · Siemens Healthcare Diagnostics
Hazard
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher. · FDA Class II
Units
1432
Sold at
Distributed to accounts located in 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 PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK ZA ES SE CH TW TH TR AE GB UY VN.
Description
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Product
Atellica CH 930 Analyzer
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →