Atellica CH 930 Analyzer recall
Atellica CH 930 Analyzer
Why was Atellica CH 930 Analyzer recalled?
Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163
- Product
- Atellica CH 930 Analyzer
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 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.
- Recall date
- December 4, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)