Recall Z-1003-2024— Siemens Healthcare Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2023-12-15. It names 2 FDA 510(k) clearances: K151767, K992662. Product: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry. Reason: Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-12-15
- Firm location
- Tarrytown, NY, United States
510(k) clearances named in this recall
2 on FDA's record- K151767 — Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
- K992662 — 8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Reason for recall
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
Data sourced from openFDA. This site is unofficial and independent of the FDA.