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Atellica IM 1300 Analyzer - multi-component system for in… recallZ-2027-2021 · Siemens Healthcare Diagnostics, Inc. · initiated May 13, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Component design/selection

What the company is doing

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

Recall details

Recall number
Z-2027-2021
Status
Open, Classified
Initiated by the company
May 13, 2021
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
US: 233 OUS: 233
Product code
JLW
FDA submissions
K151792
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

Product description

Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

Code information (models, lots, serial numbers)

Effected Serial Range: IM00873 IM01452 and IRM00256xxxx IRM01169xxxx Note: xxxx in serial number is any number.   UDI: 00630414007960

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K151792 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88056).

Sources and updates

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