[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
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066001 |
|---|---|
| Brand / manufacturer | Siemens Healthcare Diagnostics, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1252-2022 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 April 2022 |
| EAN / barcode | 00630414007960 |
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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