Recall Z-0052-2021 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
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
| Date | Aug 19, 2020 |
| Status | Terminated |
| Reason | 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 | 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. R |
| Quantity | 533 US and 1822 OUS |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay Siemens Healthcare Diagnostics, Inc., May 17, 2019 |