| | Class 2 Device Recall Siemens Atellica CH Reaction Ring Cuvette Segment |  |
| Date Initiated by Firm | October 21, 2024 |
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| Date Posted | November 20, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0496-2025 |
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| Recall Event ID |
95626 |
| 510(K)Number | K161954 |
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| Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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| Product | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes and present them to each processing step.
Siemens Material Number(SMN): 11099326
All lots starting with N15 or 15 are expected to have the defect. |
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| Code Information |
Lot # UDI
N1527024 (01)00630414596143(10)N1527024(17)20291002;
N1526424 (01)00630414596143(10)N1526424(17)20291001;
N1525924 (01)00630414596143(10)N1525924(17)20290924 ;
N1525324 (01)00630414596143(10)N1525324(17)20290918 ;
N1524224 (01)00630414596143(10)N1524224(17)20290911;
N1523724 (01)00630414596143(10)N1523724(17)20290904;
N1523024 (01)00630414596143(10)N1523024(17)20290827;
N1521824 (01)00630414596143(10)N1521824(17)20290814;
N1521424 (01)00630414596143(10)N1521424(17)20290808;
N1519324 (01)00630414596143(10)N1519324(17)20290719;
N1518924 (01)00630414596143(10)N1518924(17)20290716;
N1518224 (01)00630414596143(10)N1518224(17)20290710;
N1518324 (01)00630414596143(10)N1518324(17)20290710;
N1516224 (01)00630414596143(10)N1516224(17)20290621;
N1515624 (01)00630414596143(10)N1515624(17)20290612;
N1514924 (01)00630414596143(10)N1514924(17)20290605;
N1514124 (01)00630414596143(10)N1514124(17)20290530;
N1513324 (01)00630414596143(10)N1513324(17)20290522;
N1512824 (01)00630414596143(10)N1512824(17)20290515;
N1512424 (01)00630414596143(10)N1512424(17)20290510;
N1511224 (01)00630414596143(10)N1511224(17)20290506;
N1510724 (01)00630414596143(10)N1510724(17)20290423;
N1510124 (01)00630414596143(10)N1510124(17)20290419.
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| FEI Number |
2432235
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Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
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| For Additional Information Contact | SAME
914-631-8000 |
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Manufacturer Reason
for Recall | A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for
seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine
Kinase (CK), Cystatin C, and Salicylate. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Siemens issued Urgent Medical Device Correction (UMDC) to l US affected customers
via FedEx beginning on 10/21/2024. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites with affected customers beginning on 10/21/2024.
In accordance with outside US country regulations, Siemens in-country personnel for the EU and non-EU regions follow local requirements for contacting their respective National Competent Authorities.
Letter states reason for recall, health risk and action to take:
Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
Review your current Atellica CH Reaction Ring Cuvette Segment stock. All Atellica CH
Reaction Ring Cuvette Segments beginning with 11 are not part of this communication
and can be used without restriction. Any other lot in your stock must be immediately
discarded.
Locate your analyzer s serial number within the Appendix B Serial Number List. If your
analyzer s serial number is in the provided list, perform the instructions in Appendix A to
assess, inspect, and/or replace the Atellica CH Reaction Ring Cuvettes Segments.
Determine your laboratory s replacement needs and provide detailed information to
Siemens Healthineers for reporting to authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days.
Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Siemens Healthineers has confirmed Atellica CH reaction ring segments beginning with lot number 11 are not impacted, and going forward all future lots will work as expected.
If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
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| Quantity in Commerce | 9729 units |
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| Distribution | US Nationwide and Worldwide distribution:
Foreign:
Algeria
Algeria
Argentina
Australia
Austria
Bahrain
Bangladesh
Belgium
Brazil
Bulgaria
Burkina Faso
Canada
Chile
China
Colombia
Congo, Republic
C¿te dIvoire
Croatia
Cyprus
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Iran, Islamic Republic of
Iraq
Ireland
Israel
Italy
Japan
Jordan
Kenya
Kuwait
Latvia
Libya
Malaysia
Mexico
Moldova, Rep. of
Morocco
Nepal
Netherlands
Norway
Oman
Pakistan
Paraguay
Peru
Philippines
Poland
Portugal
Qatar
Republic Korea
Romania
Russian Federation
Saudi Arabia
Serbia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan, Province of China
Thailand
Tunisia
Turkey
Uganda
Ukraine
United Arab Emirates
United Kingdom Great Britain
Uruguay
Vatikancity
Vietnam
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JJE
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