Recall Z-2431-2020— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2020-06-05, terminated 2021-11-18. It names one FDA 510(k) clearance: K161494. Product: Atellica CH Chemistry Calibrator. 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-06-05
- Terminated
- 2021-11-18
- Firm location
- Tarrytown, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Atellica CH Chemistry Calibrator
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.