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

Recall number

Z-1252-2022

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

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

Status

Open, Classified

Initiated

2022-04-13

Posted

not on file

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

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.

Quantity

1,566

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.

Lot, serial or model codes

UDI: 00630414007960 All lots

510(k) numbers

["K151792"]

PMA numbers

not on file

Product code

JLW

Firm FEI

2432235

Firm city

Tarrytown

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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