Z-1341-2022 Class II Terminated
FDA device recall Z-1341-2022 was initiated by Siemens Healthcare Diagnostics, Inc. on May 18, 2022 and is designated Class II. 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… The recall status is terminated (terminated Feb 13, 2025). Affected quantity: 113 units; Extended: 52 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 13, 2022
- Initiation Date
- May 18, 2022
- Termination Date
- Feb 13, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113 units; Extended: 52 units
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
Distribution Pattern
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.
Code Information
UDI-DI: 00842768013836GA232320221119 Lot Number: GA2323 Exp. Date: 11-19-2022 Recall Extended 9/21/22: UDI: 00842768013836BA308820230329 Lot Number: BA3088 Exp. Date: 2023-03-29
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1341-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026