FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: 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.
- Recall number
- Z-0899-2010
- Recalling firm
- Pointe Scientific, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-11-16
- Posted
- 2010-03-02
- Terminated
- 2011-06-06
- Reason
- Turbidity formation could occur, resulting in invalid test results being reported out.
- 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
- 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.
- Lot, serial or model codes
- All lot numbers containing the numbers 735401 or 816501.
- 510(k) numbers
- ["K864882"]
- PMA numbers
- not on file
- Product code
- JIY
- Firm FEI
- 1827821
- Firm city
- Canton
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28