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[Recalled] Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 — Lots incompatible with Test Definition (TDef) Version 1.4

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductAtellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001
Brand / manufacturerSiemens Healthcare Diagnostics, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1252-2022
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date13 April 2022
EAN / barcode00630414007960

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Lots incompatible with Test Definition (TDef) Version 1.4, potentially lead to the generation of erroneous total T3 results

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Siemens Healthcare Diagnostics, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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