Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-2341-2019

Z-2341-2019 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
August 28, 2019
Initiation Date
June 27, 2019
Termination Date
May 27, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
664 units

Product Description

N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Material Number (SMN):10446539

Reason for Recall

Iincreased (falsely elevated) Albumin results compared to expected results

Distribution Pattern

Nationwide

Code Information

Lot # 5890128326 and Lot # 182670004 UDI: 00842768012334

Other recalls by Siemens Healthcare Diagnostics, Inc.

  • Z-2005-2026 Class II — epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Ma (April 2, 2026)
  • Z-1980-2026 Class II — Dimension Creatinine Flex reagent cartridge. Material Number: 10872079. (March 18, 2026)
  • 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-0491-2026 Class II — IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038610 (October 6, 2025)
  • Z-0493-2026 Class II — Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catal (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)