Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1340-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: May 18, 2022

Date Posted: July 13, 2022

Recall Number: Z-1340-2022

Event ID: 90387

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

Status: Terminated

Product Quantity: 76 units

Code Information:

UDI-DI: 00842768013904EA231420221110 Lot Number: EA2314 Exp. Date: 11-10-2022

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.

Voluntary or Mandated:

Voluntary: Firm initiated