Recall Z-0899-2010 ยท JIY Photometric Method, Iron (Non-Heme)
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.
| Date | Mar 2, 2010 (initiated Nov 16, 2009) |
| Status | Terminated |
| 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 Vene |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K864882 | FERROZINE (COLORIMETRIC) IRON BINDING CAPACITY Pointe Scientific, Inc.,, Jan 21, 1987 |