[Recalled] Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibrati
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system. |
|---|---|
| Brand / manufacturer | Siemens Healthcare Diagnostics, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0116-2019 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 24 July 2018 |
| EAN / barcode | 10995532 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A potential bias was identified with certain kits compared to the internal standards.
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 →
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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.