Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1341-2022)

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 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

Product Classification:

Class II

Date Initiated: May 18, 2022

Date Posted: July 13, 2022

Recall Number: Z-1341-2022

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: 113 units; Extended: 52 units

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

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