Recall Z-2431-2020 ยท CGX Alkaline Picrate, Colorimetry, Creatinine
Siemens Healthcare Diagnostics, Inc.
Atellica CH Chemistry Calibrator
| Date | Jun 5, 2020 |
| Status | Terminated |
| Reason | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens Healthcare Diagnostics sent a letter notification sent to customers dated June 10, 2020. As one of the short-term alternatives for customers, where regulations permit, Siemens has evaluated the use of the lyophilized RANDOX Calibration Serum Level 3 Lot 1024UE. (CAL 3) for generating DBIL_2/DBil_2 and TBIL_2/TBil_2 results until a new lot of unaffected Siemens Chemistry Calibrator is available. |
| Quantity | 1522 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161494 | Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) Siemens Healthcare Diagnostics, Inc., Nov 15, 2016 |