Recall Z-0906-2010
Pointe Scientific, Inc. · initiated November 16, 2009
Product
Pointe Scientific Iron Reagent (R2), for the quantitative determination of serum iron, Pointe Scientific, Inc, Canton, MI, Catalog #: 8HI904-R2-100.
Codes / lots: All lot numbers containing the numbers 735401 or 816501.
Reason for recall
Turbidity formation could occur, resulting in invalid test results being reported out.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0906-2010
- Initiated
- November 16, 2009
- Posted by FDA
- March 2, 2010
- Terminated
- June 6, 2011
- Product code
- JIY – Photometric Method, Iron (Non-Heme)
- Quantity
- 2
- 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.
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0899-2010 | Pointe Scientific Iron/TIBC Reagent Set, for the quantitative determination of serum…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0900-2010 | Pointe Scientific Total Iron Reagent Set, for the quantitative determination of serum…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0901-2010 | Pointe Scientific Iron (Ferrozine) Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0902-2010 | Pointe Scientific Iron (Ferrozine) R1 Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0903-2010 | Pointe Scientific Iron (Ferrozine) R2 Reagent Set, for the quantitative determination of…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0904-2010 | Pointe Scientific, Inc. Iron Buffer Reagent, Pointe Scientific, Inc., Canton, MI.…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |
| Z-0905-2010 | Pointe Scientific, Inc. Iron Color Reagent, Pointe Scientific, Inc., Canton, MI.…Turbidity formation could occur, resulting in invalid test results being reported out. | 11/16/2009Terminated |