Recall Z-1341-2022— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2022-05-18, terminated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C. Reason: Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-05-18
- Terminated
- 2025-02-13
- Firm location
- Newark, DE, United States
Product description
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
Reason for recall
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Data sourced from openFDA. This site is unofficial and independent of the FDA.