Recall Z-1340-2022 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Dimension LTNI -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): 10444896/RF521
| Date | Jul 6, 2022 (initiated May 18, 2022) |
| Status | Terminated |
| 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 |
| Root cause | Under Investigation by firm |
| Action | ****Recall Expanded 9-21-22*** US Customers were sent Urgent Medical Device Correction (DC-22-2.B.US) on 09/21/2022 and an Urgent Field Safety Notice UFSN DC-22-02.B.OUS) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 09/26/2022. Letter informs them to use serum patient samples only when utilizing lot BA3088. Laboratories unable to use serum patient samples for testing are to request a no charge replacement for their impacted reagent. Siemens issued Urgent Medical Device Correc |
| Quantity | 76 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.