Siemens Healthcare Diagnostics, Inc. recalls Atellica CH 930 Analyzer
- Recall date
- September 23, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0581-2020
- FDA classification
- Class II
- Brand / firm
- Siemens Healthcare Diagnostics, Inc.
- Sold / distributed
- 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…
Why it was recalled
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Atellica CH 930 Analyzer
Get recall alerts
Free email alert whenever Siemens Healthcare Diagnostics, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Siemens Healthcare Diagnostics, Inc.