Drug recall
Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement…
FDA recall event 82990 · Class II · Siemens Healthcare Diagnostics Inc
Key facts
| Event ID | 82990 |
|---|---|
| Recall numbers | Z-2135-2019 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Product type | Devices |
| Products | Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the measurement of cardiac troponin I in heparinized plasma. Cardiac troponin I measurements can be used as… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for increased rate of false positive results and/or increased rate of random non-repeatable false positive results. |
| Initiation date | May 29, 2019 |
| Report date | Aug 7, 2019 |
| Termination date | May 12, 2022 |
| City | Norwood |
| State | MA |
| Country | United States |
| FEI number | 3002637618 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: