Z-1252-2022Class II

Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on...

Name: Z-1252-2022 Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-04-13
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-04-13 / Open, Classified

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN)... on 2022-04-13. FDA classified it as Class II and gives the reason as "Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1252-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-13
Posted: 2022-06-09
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
Product code: JLW Radioimmunoassay, Thyroid-Stimulating Hormone
Reason for recall: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results
FDA 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 in commerce: 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.
Product codes and lots: UDI: 00630414007960 All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1252-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1252-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-09
Z-1253-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-09

Product code JLW

K151792Class IITrinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc. / cleared 2015-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)