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Terminated

Atellica CH Chemistry Calibrator

FDA Recall Z-2431-2020 · Posted None

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCGX
Date Initiated2020-06-05
Date Terminated2021-11-18
Product Quantity1522 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)Siemens Healthcare Diagnostics, Inc. · 2016-11-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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