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Atellica IM 1300 Analyzer - automated, immunoassay analyzer… recallZ-1252-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Apr 13, 2022

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

Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens issued an Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 04/13/2022 and an Urgent Field Safety Notice (UFSN) was issued to all OUS. Letter states reason for recall, health risk and action to take: If your facility has multiple lots of T3 available for use and some kit lots are below lots ending in 244, follow the steps below to ensure that T3 results will be correct for all available lots until all kit lots available for use are kit lots ending in 244 or above. Ensure that all IM modules connected to an Atellica Solution have only 1 lot of T3 reagent (all IM modules have the same lot of T3 reagent packs) loaded onto every IM. For reagent kit lots below lots ending in 244: Rescan the Master Curve Card (MCC) for the T3 reagent lot that is on the Atellica IM before processing with that reagent lot, following instructions in the Atellica Online Help (SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D Barcodes ). Note: If the IM is rebooted while using kit lots below lots ending in 244, the MCC will need to be re-scanned before samples are processed. For reagent lots ending in 244 and above: Rescan the Master Curve Card (MCC) for the T3 reagent kit lot that is on the Atellica IM, following instructions in the Atellica Online Help (SMN 11313586, section Scanning IM Master Curves and Assay Test Definitions 2D Barcodes . Reboot all IM modules connected to Atellica Solution following instructions in the Atellica Online Help (SMN 11313586, section titled Shutting Down and Powering Off Analyzers within the System ) when changing from reagent kit lots below lots ending in 244 to a reagent pack associated with kit lots ending in 244 or above before processing with that reagent kit lot. Please review this letter with your Medical Director. Complete and return the Field Action Effectiveness Check Form attached to this letter within 30 days.

Recall details

Recall number
Z-1252-2022
Status
Open, Classified
Initiated by the company
Apr 13, 2022
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
1,566
Product code
JLW
FDA submissions
K151792
Distribution
Worldwide distribution - US Nationwide and the countries of Albania, Argentina, Austria, Bahamas, Bangladesh, Belgium, Brazil, Chile, China, Columbia, Croatia, Czech¿Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, India, Israel, Italy, Japan, Korea, Latvia, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Portugal, Romania, Russian¿Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., United Kingdom, Vietnam.

Product description

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

Code information (models, lots, serial numbers)

UDI: 00630414007960 All lots

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 90153).

Sources and updates

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