Z-0899-2010

Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding...

Name: Z-0899-2010 Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding...
Creator: Pointe Scientific, Inc.
Published: 2009-11-16
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2009-11-16 / Terminated / root cause: design

FDA source

Pointe Scientific, Inc. began a recall of Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI... on 2009-11-16. The reason FDA records is "Turbidity formation could occur, resulting in invalid test results being reported out". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0899-2010
Status: Terminated
Initiated: 2009-11-16
Posted: 2010-03-02
Terminated: 2011-06-06
Recalling firm: Horiba Instruments Incorporated
Product: Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum iron and iron binding capacity, Pointe Scientific, Inc, Canton, MI, Catalog #s: I7504-60, I7504-400, I7504-SAM, 10-I7504-60. Clinical chemistry reagent for the quantitative determination of iron in serum.
Product code: JIY Photometric Method, Iron (Non-Heme)
Reason for recall: Turbidity formation could occur, resulting in invalid test results being reported out.
Root cause tag: design
FDA root cause: Device Design
Action: Consignees were notified by recall letter dated 11/16/09 and instructed to discard any remaining product. Please call 1-800-757-5313 if you have questions.
Quantity in commerce: 417 sets
Distribution: Nationwide, Australia, Austria, Bolivia, Canada, Cyprus, Egypt, Ghana, Greece, Guyana, India, Indonesia, Israel, Jordan, Kenya, Korea, Lebanon, Macedonia, Malaysia, Mexico, Nicaragua, Nigeria, Pakistan, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Trinidad, Turkey, Ukraine and Venezuela.
Product codes and lots: All lot numbers containing the numbers 735401 or 816501.

Product code JIY

K864882Class IFerrozine (Colorimetric) Iron Binding CapacityPointe Scientific, Inc., / cleared 1987-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)