Siemens Healthcare Diagnostics Products Ltd.
FDA Regulatory Profile
Siemens Healthcare Diagnostics Products Ltd. appears in FDA public data with 2 recalls, 24 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2965-2026, Class II) was initiated on July 13, 2026. Its most recent 510(k) clearance was granted on September 4, 2026.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 24
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2965-2026 | Class II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly | July 13, 2026 |
| Z-2966-2026 | Class II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/1048 | July 13, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260331 | IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) | September 4, 2026 |
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS | October 10, 2024 |
| K233946 | IMMULITE® 2000 BR-MA | March 13, 2024 |
| K233663 | N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) | December 13, 2023 |
| K213510 | IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA | September 8, 2023 |
| K220728 | vWF Ag | June 2, 2023 |
| K212559 | CardioPhase® hsCRP | December 16, 2022 |
| DEN200067 | INNOVANCE VWF Ac | September 29, 2022 |
| K212379 | N Latex FLC kappa, N Latex FLC lambda | March 2, 2022 |
| K201496 | N Latex FLC kappa, N Latex FLC lambda | October 29, 2021 |
| K193047 | N Latex FLC kappa, N Latex FLC lambda | July 14, 2021 |
| K203270 | IMMULITE/IMMULITE® 1000 Cortisol | January 15, 2021 |
| K202826 | IMMULITE® 2000 Cortisol | January 15, 2021 |
| K190879 | N Latex FLC kappa, N Latex FLC lambda | May 3, 2019 |
| K182098 | N Latex FLC kappa assay, N Latex FLC lambda assay | November 1, 2018 |
| K181525 | INNOVANCE Free PS Ag | September 7, 2018 |
| K171742 | N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 | November 17, 2017 |
| K172333 | Sysmex CS-5100 | October 31, 2017 |
| K171072 | N Latex Cystatin C; N Protein Standard UY | May 12, 2017 |
| K162688 | Sysmex CS-2100i | December 26, 2016 |