Pointe Scientific, Inc. recalls Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one…

Recall date

December 12, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2773-2015

FDA classification

Class III

Brand / firm

Pointe Scientific, Inc.

Sold / distributed

Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.

Why it was recalled

Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.