Z-1340-2022Class II

Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human...

Name: Z-1340-2022 Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2022-05-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2022-05-18 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the... on 2022-05-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1340-2022
Classification: Class II
Status: Terminated
Initiated: 2022-05-18
Posted: 2022-07-06
Terminated: 2025-02-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: 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
Product code: MMI Immunoassay Method, Troponin Subunit
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
FDA 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 in commerce: 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.
Product codes and lots: UDI-DI: 00842768013904EA231420221110 Lot Number: EA2314 Exp. Date: 11-10-2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1340-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1340-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-06
Z-1341-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-06

Product code MMI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)