Siemens Healthcare Diagnostics, Inc.: Atellica CH Chemistry Calibrator

Is my product affected?

Atellica CH Chemistry Calibrator

• UPC 00630414597492

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

What happened

Siemens Healthcare Diagnostics is recalling Chemistry Calibrator products used with ADVIA Chemistry and Atellica CH laboratory analyzers due to calibration errors affecting Total and Direct Bilirubin assays. The recall involves 1,522 units distributed nationwide, specifically lot 534179 (with sublots A through E) and lot 911591 (with sublots A through C), with various expiration dates ranging from October 2021 through March 2022.

The affected products are identified by their UDI codes and lot numbers listed in the recall notice. The source document does not specify what actions affected consumers or healthcare facilities should take in response to this recall.

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: 1522 units Lot/code info: 534179 (including sublots A, B, C, D and E) 911591 (including sublots A, B, and C) UDI: (01)00630414597492(10)534179(17)20211031 (01)00630414597492(10)534179A(17)20211231 (01)00630414597492(10)534179B(17)20211231 (01)00630414597492(10)534179C(17)20220131 (01)00630414597492(10)534179D(17)20220131 (01)00630414597492(10)534179E(17)20220331 (01)00630414597492(10)911591(17)20220331 (01)00630414597492(10)911591A(17)20220531 (01)00630414597492(10)911591B(17)20220531 (01)00630414597492(10)911591C(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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