Siemens Healthcare Diagnostics, Inc.: ADVIA Chemistry Calibrator

Is my product affected?

ADVIA Chemistry Calibrator

• UPC 00630414223414

Check against the official notice below — it lists the full affected range.

What happened

Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Calibrator lot 534177 and Atellica CH Calibrator lot 534179 because calibration errors have been observed with the Total and Direct Bilirubin assays when using these products. The recall affects 1,872 units distributed nationwide in the United States.

The recall notice does not specify a remedy or instructions for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 from the source

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. Distribution: US Nationwide Distribution Quantity: 1872 units Lot/code info: Lots: 534177 (including sublots A, B and C) 960742 UDI: (01)00630414223414(10)534177(17)20210930 (01)00630414223414(10)534177A(17)20211031 (01)00630414223414(10)534177B(17)20211231 (01)00630414223414(10)534177C(17)20220131 (01)00630414223414(10)534177D(17)20220331 (01)00630414223414(10)960742(17)20220531

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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