Siemens Healthcare Diagnostics Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 684 (13 Class I)
- 510(k) Clearances
- 244
- Inspections
- 41
- Compliance Actions
- 3
Known Names
siemens healthcare diagnostics, siemens healthcare diagnostics products
Recent Recalls
| Number | Class | Product | Date |
|---|
| 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): 10386105; Catalog Number: | October 6, 2025 |
| Z-0493-2026 | Class II | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4; | October 6, 2025 |
| Z-0492-2026 | Class II | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UN | October 6, 2025 |
| Z-0366-2026 | Class II | Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) | September 22, 2025 |
| Z-2542-2025 | Class II | Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543. | 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-2087-2025 | Class II | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control) | June 4, 2025 |
| Z-2086-2025 | Class II | ADVIA¿ 120/2120/2120i SETpoint Calibrator | June 4, 2025 |
| Z-2089-2025 | Class II | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control) | June 4, 2025 |
| Z-2088-2025 | Class II | ADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control) | June 4, 2025 |
| Z-2027-2025 | Class II | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300; | May 22, 2025 |
| Z-1821-2025 | Class II | Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498 | April 15, 2025 |
| Z-1822-2025 | Class II | ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376. | April 15, 2025 |
| Z-1673-2025 | Class II | Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma. | March 31, 2025 |
| Z-1684-2025 | Class II | epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 1 | March 19, 2025 |
| Z-1685-2025 | Class II | epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): | March 19, 2025 |
| Z-1551-2025 | Class II | Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223. | March 11, 2025 |
| Z-0734-2025 | Class II | epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Inten | November 22, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251998 | Atellica CH Diazo Total Bilirubin (D_TBil) | February 27, 2026 |
| K251543 | Atellica® IM TSH3-Ultra II (TSH3ULII) | February 6, 2026 |
| K251630 | Atellica IM Total PSA II (tPSAII) | January 5, 2026 |
| K250816 | ADVIA Centaur Anti-Thyroglobulin II (aTgII) | December 4, 2025 |
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | October 17, 2025 |
| K242981 | Atellica IM Thyroglobulin (Tg) | June 20, 2025 |
| K243570 | Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyrox | April 25, 2025 |
| K242685 | Atellica® CH Creatinine_3 (Crea3) | December 4, 2024 |
| K241800 | Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) | July 26, 2024 |
| K241165 | Atellica® IM High-Sensitivity Troponin I (TnIH) | July 25, 2024 |
| K233050 | ADVIA Centaur® TSH3-Ultra II (TSH3ULII) | April 4, 2024 |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | January 18, 2024 |
| K220265 | ADVIA Centaur® NT-proBNPII (PBNPII) | September 24, 2023 |
| K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | August 8, 2023 |
| K222438 | A-LYTE® Integrated Multisensor (IMT Na K Cl) | July 25, 2023 |
| K221605 | Emit® II Plus Buprenorphine Assay | July 25, 2023 |
| K222116 | Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albu | July 13, 2023 |
| K223078 | Atellica® CH Diazo Direct Bilirubin (D_DBil) | June 12, 2023 |
| K221801 | ADVIA Centaur® Anti-Müllerian Hormone (AMH) | June 2, 2023 |
| K222104 | Atellica® CH Diazo Total Bilirubin (D_TBil) | March 20, 2023 |