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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH 930 Analyzer

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 Class 2 Device Recall Atellica CH 930 Analyzersee related information
Date Initiated by FirmSeptember 23, 2019
Create DateNovember 27, 2019
Recall Status1 Terminated 3 on July 06, 2022
Recall NumberZ-0581-2020
Recall Event ID 83946
510(K)NumberK151767 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductAtellica CH 930 Analyzer
Code Information SMN 11067000, Software V1.20.0 and Lower, UDI 00630414002163
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.
FDA Determined
Cause 2		Software design
ActionSiemens issued an Urgent medical Device Correction, (UMDC ASW19-06.A.US) and Urgent Field Safety Notification (UFSN ASW19-06.A.OUS) to all affected Customers via Certified Mail (domestic) and e-mail (international) beginning on 2019-09-23. It included the following instructions to the user: Actions to be Taken by the Customer 1. Do not order Reagent Pack Calibration (C0 Adjust) while the Reagent Lot calibration is in progress. 2. Always run QC after calibration before running patient samples. If QC is ordered with calibration and it recovers out of range high, the calibration status will be 'Awaiting Acceptance'. Reject and re-order the calibration. - Please review this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - If you have received any complaints of illness or adverse events associated with the product listed immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Quantity in Commerce1432
DistributionDistributed 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.
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 = JJE
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