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
Reported: July 13, 2022 Initiated: May 18, 2022 #Z-1341-2022
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
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 113 units; Extended: 52 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 113 units; Extended: 52 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 13, 2022. Severity: Moderate. Recall number: Z-1341-2022.
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