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Terminated

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.

FDA Recall Z-0899-2010 · Posted 2010-03-02

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeJIY
Date Initiated2009-11-16
Date Terminated2011-06-06
Product Quantity417 sets

Reason for Recall

Turbidity formation could occur, resulting in invalid test results being reported out.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K864882FERROZINE (COLORIMETRIC) IRON BINDING CAPACITYPointe Scientific, Inc., · 1987-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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