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Pointe Scientific, Inc.

HORIBA INSTRUMENTS INCORPORATED · Model HI904-600 · UDI-DI 00811727012708

JIY Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Iron (Ferrozine) Reagent, for the quantitative determination of iron in serum on Hitachi analyzers. For in vitro diagnostic use only. Size: 5 x 100ml,1 x 100ml

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2024-03-13	Siemens 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. Results in a positiv
2023-09-29	Sentinel CH SpA	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for
2023-09-29	Sentinel CH SpA	A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for
2022-06-28	Siemens 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 run immediately aft
2016-08-25	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instruct
2016-08-25	Siemens Healthcare Diagnostics, Inc.	Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than listed in the Instruct
2016-07-20	Sterling 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 kits.
2013-06-12	Ortho-Clinical Diagnostics	Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.
2012-10-08	Siemens 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 well set contaminated w

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.