Pointe Scientific, Inc. Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1. Clinical chemistry reagent for the quantitative determination of iron in serum. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: HI404-R1. Clinical chemistry reagent for the quantitative determination of iron in serum.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
All lot numbers containing the numbers 735401 or 816501.
Products Sold
All lot numbers containing the numbers 735401 or 816501.
Pointe Scientific, Inc. is recalling Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of serum iron, due to Turbidity formation could occur, resulting in invalid test results being reported out.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Turbidity formation could occur, resulting in invalid test results being reported out.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026