—#181893

Product

Atellica CH Chemistry Calibrator

FDA product code: CGX — Alkaline Picrate, Colorimetry, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K161494
Affected 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

Why it was 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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 511 Benedict Ave, Tarrytown, New York 10591-5005

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2020-06-05
Terminated: 2021-11-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181893. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.