Siemens Healthcare Diagnostics, Inc.: 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

Recall number

Z-1341-2022

Recalling firm

Siemens Healthcare Diagnostics, Inc.

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

Status

Terminated

Initiated

2022-05-18

Posted

2022-07-06

Terminated

2025-02-13

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 Correction (UMDC) to US affected customers by FedEx beginning on 05/18/2022. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites for distribution and regional reporting to their local competent authorities beginning on 05/18/2022. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Siemens recommends using serum patient samples only when using the lots listed in Table 1. If your laboratory is not able to use serum samples, please discard the reagent and complete the attached Product Replacement form for a no-charge replacement product. Review your inventory to determine possible replacement needs and to provide information to Siemens for reporting to the Authorities. Complete and return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.

Quantity

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

MMI

Firm FEI

2517506

Firm city

Newark

Firm state

DE

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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