FDA Device Recall Z-0052-2021: Siemens Healthcare Diagnostics, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0052-2021.

Recall Res Number

Z-0052-2021

Recalling Firm / Manufacturer

Siemens Healthcare Diagnostics, Inc.

FEI Number

2517506

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2020-08-19

Date Posted

N/A

Date Terminated

2023-08-25

Product Code

MMI

Event Number

86374

Product Quantity

533 US and 1822 OUS

Product Description 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

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

Action Details 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.

Distribution Pattern US Nationwide distribution.

Code Information / Serial Numbers Lot # EB0255 UDI: 00842768037726EB025520091110471068840

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Medical Device Recall: Z-0052-2021

Recall Parameters & Description

Related Establishments / Registrations

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