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Photometric Method, Iron (Non-Heme)

FDA product code JIY · Class 1 · Clinical Chemistry

58
Registered devices
55
Adverse events
19
Recalls
67
510(k) clearances

Devices with this code

Alinity — ABBOTT LABORATORIESACE — ALFA WASSERMANN, INC.Sirrus® Total Iron LiquiColor® — STANBIO LABORATORY, L.P.ARCHITECT — ABBOTT IRELANDMedTest DX Total Iron / BS200 — Medtest Dx, Inc.Teco Diagnostics Iron Reagent Kit for TC Matrix — TECO DIAGNOSTICSJAS Diagnostics — DREW SCIENTIFIC, INC.ADVIA® Chemistry IRON_2 Reagents — Siemens Healthcare Diagnostics Inc.Pointe Iron Reagent — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDUnsaturated Iron-Binding Capacity — Roche Diagnostics GmbHClearChem Diagnostics Inc. Iron — CLEARCHEM DIAGNOSTICS INC.MedTest DX Total Iron / BS480 — Medtest Dx, Inc.Alinity — ABBOTT IRELANDIron Gen.2 — Roche Diagnostics GmbHCAROLINA LIQUID CHEMISTRIES CORP.® IRON REAGENT KIT DT618 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAU — Beckman Coulter, Inc.Pointe Scientific, Inc. Iron (Ferrozine) Reagent — HORIBA INSTRUMENTS INCORPORATEDIRON Gen.2 — Roche Diagnostics GmbHAtellica CH Iron3 (Iron3) — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDIron Reagent Set — CLINICAL DIAGNOSTIC SOLUTIONS, INC.ARCHITECT — ABBOTT LABORATORIESADVIA® Chemistry IRON_2 Iron 2 Reagents — Siemens Healthcare Diagnostics Inc.

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.