Z-0052-2021Class II

Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the...

Name: Z-0052-2021 Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2020-08-19
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-08-19 / Terminated

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in... on 2020-08-19. FDA classified it as Class II and gives the reason as "Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0052-2021
Classification: Class II
Status: Terminated
Initiated: 2020-08-19
Posted: 2020-10-02
Terminated: 2023-08-25
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use in the quantitative measurement of cardiac troponin I in human plasma Catalog Number: RF627, SMN# 10471068
Product code: MMI Immunoassay Method, Troponin Subunit
Reason for recall: Positive bias across the Analytical Measurement Range of the TNIH assay compared to an unaffected control lot. The average bias observed for patient samples using lots EB0255 and EA0178 of the Dimension EXL Troponin compared with a control lot was +25%. A maximum bias of +34% in patient samples around the 99th percentile observed
FDA root cause: Under Investigation by firm
Action: Siemens issued Urgent Medical Device Correction (UMDC # VC-20-03.B.US) and Urgent Field Safety Notice (UFSN # VC-20-03.B.OUS) issued on August 19, 2020 via FedX to US Dimension customers who received the Dimension TNIH reagent lot to notify them of the issue, the risk to health, and the following actions to be taken by the customer: Review the letter with their Medical Director"If they are using TNIH lot EB0255 DO NOT switch to another TNIH lot during serial measurements for a single patient sample. Discontinue use and discard the TNIH reagent lot EB0255 upon receipt of replacement product. Request your no-charge replacement for lot EB0255. Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. Questions, contact your Siemens Remote Services Center or your local Siemens Technical Support representative.
Quantity in commerce: 533 US and 1822 OUS
Distribution: US Nationwide distribution.
Product codes and lots: Lot # EB0255 UDI: 00842768037726EB025520091110471068840

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0052-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0052-2021	Class II	Terminated	Voluntary: Firm initiated	2020-10-14	2020-10-02

Product code MMI

K190675Class IIDimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc. / cleared 2019-05-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)