Recall Z-2471-2023 · JFM Enzymatic Method, Bilirubin
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates Test Code: TBil_2 Siemens Material Number (SMN): 11097531
| Date | Aug 28, 2023 (initiated Jul 10, 2023) |
| Status | Open, Classified |
| Reason | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica CH Total Bilirubin_2 (TBil_2), AtellicaCH LDL Cholesterol (LDLC), Atellica CH Gamma-Glutamyl Transferase (GGT) and AtellicaCH HDL Cholesterol (HDLC) |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthineers issued Urgent Medical Device Correction ACHC23-01.C.US to US affected customers via FedEx beginning on 07/10/2023; and Urgent Field Safety Notice ACHC23-01.C.OUS,OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 07/10/2023. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. Perform the instructions provided |
| Quantity | 50148 units |
| Distribution | US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay Vietnam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) Siemens Healthcare Diagnostics, Inc., Mar 9, 2017 |