Atellica CH 930 Analyzer
Reported: December 4, 2019 Initiated: September 23, 2019 #Z-0581-2020
Product Description
Atellica CH 930 Analyzer
Reason for Recall
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1432
- Distribution
- 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.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
Atellica CH 930 Analyzer. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1432.
Why was this product recalled? ▼
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0581-2020.
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