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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 013 10 18 000
Date submitted: 10/7/2018
Manufacturer:Siemens Healthcare Diagnostics
Device Type:Atellica® IM 1300 Analyzer, Atellica® IM 1600 Analyzer, Atellica® CH 930 Analyzer, and Atellica® Sample Handler Prime .
Description:IVD, Chemiluminescent immunoassay analyser IVD, automated
Medical Device Identifier:Product : (Siemens Material Number (SMN))
1) Atellica IM 1300 Analyzer: ( 11066001 )
2) Atellica IM 1600 Analyzer: ( 11066000 )
3) Atellica CH 930 Analyzer : ( 11067000 )
4) Atellica Sample Handler Prime: ( 11069001 )
Reason of Field Safety Corrective Action:Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower.
Remedy Action:The following actions must be taken until your system has been updated with software version 1.15 which resolves issues 1-4.

1. The system must be safely stopped prior to opening the Atellica Magline Transport covers. Please follow the procedure “Removing Atellica Magline Transport Covers” by searching the Atellica Solution online help or refer to the Operator’s guide (April 2018). To replace the covers and resume operation, follow the procedure “Installing Atellica Magline Transport Covers” as detailed in the Atellica Solution online help or Operator’s Guide (April 2018).

2. Check the Onboard Stability of T3/T4/VB12 Ancillary Reagent packs daily and replace them before they expire:
- On the command bar select Inventory > Reagent Overview
- For any T3/T4/VB12 Ancillary Reagent packs, review the Onboard Stability
- Replace any pack before the Onboard Stability reaches 0d 0h.

3. If a T4 calibration fails, increase the number of replicates in the Calibration order as follows:

- Step 1: Determine how many replicates failed with a ‘signal error’.

- Step 2: Determine the minimum required replicates from the Test Definition screen: (Setup > Test Definition > IM Test Definition) by selecting the assay from the Test list and choosing the Calibration tab.

- Step 3: Set the number of replicates on the Calibration Order screen: (Calibration->Create Calibration Orders->Edit Cal Order) to the total of (Step 1 + Step 2).

4. Do not order H, I, or L serum indices in the same order with ALT, AST, LDLP, or UN_c tests. In order to get correct serum indices values, order the serum indices on the system or from the LIS, in a separate order without any of the donor methods (ALT, AST, LDLP, or UN_c). Alternatively, automatic HIL ordering can be turned off from the settings screen: (Setup->Settings->General Setup->Patient->HIL Ordering) by selecting “Never Automatically order.
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 Customer Care Center or your local technical support provider.
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:60ADE2A6AD342
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Siemens Healthcare Diagnostics.pdf