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Atellica IM 1300 Analyzer - Product Usage: automated… recallZ-0473-2021 · Siemens Healthcare Diagnostics, Inc. · initiated Oct 26, 2020

Terminated

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

Test Definition scanning may reset custom settings to defaults causing falsely low or high results. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens issued an Urgent Medical Device Correction (UMDC ASW21-01.A.US) via Fed'X to US Customers on 10/26/20 and Urgent Field Safety Notice, (UFSN ASW21-01.A.OUS) via electronic distribution to regional countries for implementation Outside US (OUS) The UMDC and UFSN explain the behaviors that can occur and instructs customers on actions to be taken for the issues described in the communication. Customers are requested to return the attached effectiveness check form via fax or email. A software version correcting the issues will be released when available and all systems will be updated.

Recall details

Recall number
Z-0473-2021
Status
Terminated
Initiated by the company
Oct 26, 2020
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
US 392 units; OUS 449 units
Product code
JLW
FDA submissions
K151792
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., Ukraine, United Kingdom, Uruguay, Vatikancity, Vietnam.

Product description

Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001

Code information (models, lots, serial numbers)

Software version: V1.23.1 or lower 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 86718).

Sources and updates

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