—#183505

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

FDA product code: MMI — Immunoassay Method, Troponin Subunit
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K190675
Affected lot / code info: Lot # EB0255 UDI: 00842768037726EB025520091110471068840

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr, Newark, Delaware 19702-2466

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-08-19
Terminated: 2023-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183505. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.