Device product
Atellica CH 930 Analyzer
Z-0581-2020
Product summary
- Event
- Event 83946
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1432
- Official record key
device-enforcement:Z-0581-2020
Official wording
Reason: Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Code information: SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163
Distribution pattern: 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.
Derived failure modes
-
Unknown
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.