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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Ethyl Alcohol

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 Class 2 Device Recall Atellica CH Ethyl Alcoholsee related information
Date Initiated by FirmFebruary 14, 2020
Date PostedFebruary 27, 2020
Recall Status1 Terminated 3 on February 22, 2024
Recall NumberZ-1599-2020
Recall Event ID 85020
510(K)NumberK071811 
Product Classification Alcohol dehydrogenase, specific reagent for ethanol enzyme method - Product Code DIC
ProductAtellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 00630414596112. The product is an ethyl alcohol assay, IVD use.
Code Information All in-date lots: 190133, 190222  ***Updated 4/6/2020*** New lot added: 100066   ***Updated 9/4/20*** New lot added: 100168
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactMir Khan
914-631-8000
Manufacturer Reason
for Recall		The assay may exhibit a positive bias in QC and patient results within the 10-day pack calibration interval.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn February 11, 2020, the firm issued an Urgent Medical Device Correction to all US customers. Customers who experience the issue were instructed to perform a pack calibration every 2 days or more frequently based on the laboratory's Quality Control performance. The firm is working to address the issue in a future software version. Customers are requested to complete and return the effectiveness check questionnaire. If you have any questions, contact your local Siemens Healthineers technical support representative.
Quantity in Commerce1124
DistributionDomestic distribution nationwide. Foreign distribution to Australia, Austria, Bahamas, Belgium, Canada, Curacao, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Kenya, Latvia, Mexico, Netherlands, Norway, Poland, Portugal, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Uruguay, United Kingdom, and Vietnam.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DIC
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