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Photometric Method, Iron (Non-Heme)

FDA product code JIY · Class 1 · Clinical Chemistry

58
Registered devices
56
Adverse events
19
Recalls
67
510(k) clearances

Devices with this code

Iron — Sekisui Diagnostics, LLCClearChem Diagnostics Inc. Iron — CLEARCHEM DIAGNOSTICS INC.ARCHITECT — ABBOTT IRELANDAU — Beckman Coulter, Inc.Unsaturated Iron-Binding Capacity — Roche Diagnostics GmbHADVIA® Chemistry IRON_2 Reagents — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDIron Gen.2 — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Iron — HORIBA INSTRUMENTS INCORPORATEDMedTest DX Total Iron / BS480 — Medtest Dx, Inc.Teco Diagnostics Iron Reagent Kit for TC Matrix — TECO DIAGNOSTICSAlinity — ABBOTT LABORATORIESDimension® Flex® reagent cartridge IRON — Siemens Healthcare Diagnostics Inc.Iron Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDDimension Vista® Flex® reagent cartridge IRON — Siemens Healthcare Diagnostics Inc.Direct TIBC Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Pointe Scientific, Inc. Iron (Ferrozine) Reagent — HORIBA INSTRUMENTS INCORPORATEDCAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT CC618 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Iron Reagent — HORIBA INSTRUMENTS INCORPORATED

Recent recalls

DateFirmReason
2025-11-03GET TESTED INTERNATIONAL ABDistribution without premarket approval/clearance.
2024-03-13Siemens Healthcare Diagnostics, Inc.Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette was Iron3.
2023-09-29Sentinel CH SpAA high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples res
2023-09-29Sentinel CH SpAA high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples res
2022-06-28Siemens Healthcare Diagnostics, Inc.Falsely Elevated Atellica CH Microalbumin_2 (ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is
2016-08-25Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than li
2016-08-25Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than li
2016-07-20Sterling Diagnostics, Inc.Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the k
2013-06-12Ortho-Clinical DiagnosticsOrtho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
2012-10-08Siemens Healthcare Diagnostics, Inc.Siemens Healthcare Diagnostics has confirmed the potential for falsely elevated results with IRON Flex(R) reagent cartridges when tests are processed from a wel

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.