Home / Recalls / Siemens Healthcare Diagnostics, Inc. / Z-0205-2020

Z-0205-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
October 30, 2019
Initiation Date
August 15, 2019
Termination Date
May 5, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
166 total US: 15; OUS:151

Product Description

Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000

Reason for Recall

Issues Scanning New Reagent Lot Test Definition on the Atellica IM 1300 Analyzer and Atellica IM 1600 Analyzer SW V 1.19.0 and 1.19.2

Distribution Pattern

Nationwide Foreign: Argentina Australia Bangladesh Belgium Brazil Colombia Dominican Republic Finland France Germany Greece Italy Japan Latvia Mexico Netherlands P.R. China Republic Korea Singapore Spain Switzerland Thailand United Kingdom Vietnam

Code Information

(SW) version V1.19.0 and V1.19.2 UDI: 00630414002026

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)