Date Initiated by Firm | May 13, 2021 |
Create Date | July 07, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2028-2021 |
Recall Event ID |
88056 |
510(K)Number | K151792 |
Product Classification |
Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
|
Product | Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens
SMN 11066000 |
Code Information |
Effected serial range: IH00876 IH01451 and IRH00258xxxx IRH01169xxxx Note: xxxx in serial number is any number. UDI: 00630414002026 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact | SAME 914-631-8000 |
Manufacturer Reason for Recall | Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay. |
FDA Determined Cause 2 | Component design/selection |
Action | Siemens issued an Urgent Medical Device Correction (UMDC) ASI21-02.A.US and Urgent Field Safety Notice (UFSN) ASI21-02.A.OUS on 5/13/2021 to all affected customers informing them of the issue and providing instructions the customer must follow until their analyzer is updated with replacement valves that do not have the manufacturing defect. Siemens will release the replacement valves and will begin installation at customer sites in June 2021.
Letter states:
Actions to be Taken by the Customer
The following actions must be taken until your system has been serviced to replace any leaking
components.
1. When reporting results, ensure that all QC results are within the laboratory acceptable
range before releasing results.
A manufacturing defect in some valves may cause them to leak
Siemens Healthcare Diagnostics Inc.
2. On the Atellica CH930 Analyzer:
If any water droplets are observed on the tips of any Reaction Wash Station or Dilution Wash Station probes, contact Siemens service so that the instrument can be checked for valves that may be failing.
3. On the Atellica IM 1300 or Atellica IM 1600 Analyzers:
If any water droplets are observed forming at the tips of any Reagent probes, contact Siemens service so that the instrument can be checked for valves that may be failing.
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 products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Technical Support representative.
Siemens Service representative will be contacting your laboratory to check and replace the identified valves.
Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
Contact your Siemens Healthineers Customer Care Center or y |
Quantity in Commerce | US: 123 OUS: 751 |
Distribution | Nationwide
Foreign:
Country Name
Algeria
Argentina
Australia
Austria
Bahrain
Bangladesh
Belgium
Brazil
Bulgaria
Burkina Faso
Canada
Chile
Colombia
Croatia
Cura¿ao
Cyprus
Czech Republic
Denmark
Ecuador
Egypt
Estonia
Finland
France
Germany
Greece
Hungary
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Kenya
Kuwait
Latvia
Libya
Lithuania
Malaysia
Mexico
Morocco
Netherlands
New Zealand
Norway
Oman
P.R. China
Pakistan
Peru
Philippines
Poland
Portugal
Qatar
Republic Korea
Romania
Russian Fed.
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
U.A.E.
Uganda
Ukraine
United Kingdom
Uruguay
Vatikancity
Vietnam |
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 = JLW
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