Home / Recalls / Siemens Healthcare Diagnostics, Inc / Z-0829-2020

Z-0829-2020 Class II Terminated

Recalled by Siemens Healthcare Diagnostics, Inc — East Walpole, MA

Recall Details

Product Type
Devices
Report Date
January 29, 2020
Initiation Date
July 22, 2019
Termination Date
February 14, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12,796 kits

Product Description

Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308

Reason for Recall

Homocysteine Assay May Cause Elevated Results in the Folate Assay

Distribution Pattern

Nationwide Foreign: Armenia¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sudan¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vatikancity¿¿¿¿

Code Information

All lots

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  • 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)