ADVIA Chemistry Calibrator
Reported: July 1, 2020 Initiated: June 5, 2020 #Z-2430-2020
Product Description
ADVIA 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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 1872 units
- Distribution
- US Nationwide Distribution
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
ADVIA Chemistry Calibrator. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1872 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 1, 2020. Severity: Moderate. Recall number: Z-2430-2020.
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