Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-2431-2020

Z-2431-2020 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc. — Tarrytown, NY

Recall Details

Product Type
Devices
Report Date
July 1, 2020
Initiation Date
June 5, 2020
Termination Date
November 18, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1522 units

Product Description

Atellica CH 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.

Distribution Pattern

US Nationwide Distribution

Code Information

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

Other recalls by Siemens Healthcare Diagnostics, Inc.

  • Z-1657-2026 Class II — Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11 (February 23, 2026)
  • Z-1484-2026 Class II — Atellica CH Urine Albumin (UAlb). Material Number: 11537225 (January 20, 2026)
  • Z-0493-2026 Class II — Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catal (October 6, 2025)
  • Z-0491-2026 Class II — IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038610 (October 6, 2025)
  • Z-0492-2026 Class II — 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adj (October 6, 2025)
  • Z-0366-2026 Class II — Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN) (September 22, 2025)
  • Z-2542-2025 Class II — Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 1109754 (August 11, 2025)
  • Z-2272-2025 Class II — epoc BGEM BUN Test Card [25pk]. Material Number: 10736515. (July 7, 2025)
  • Z-2230-2025 Class II — RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097. (June 26, 2025)
  • Z-2086-2025 Class II — ADVIA¿ 120/2120/2120i SETpoint Calibrator (June 4, 2025)