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.
This recall has been terminated (originally issued March 2, 2010).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- November 16, 2009
- Posted
- March 2, 2010
- Terminated
- June 6, 2011
- Recall Number
- Z-0899-2010
- Quantity
- 417 sets
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Turbidity formation could occur, resulting in invalid test results being reported out.
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 / Code Info
All lot numbers containing the numbers 735401 or 816501.
Root 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.
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