Recall Z-2773-2015— Pointe Scientific, Inc.

Name: FDA recall Z-2773-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-12

Class III · Terminated

Class III FDA medical device recall by Pointe Scientific, Inc., initiated 2014-12-12, terminated 2015-10-29. It names one FDA 510(k) clearance: K830556. Product: 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.. Reason: 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..

Recalling firm: Pointe Scientific, Inc.
Classification: Class III
Status: Terminated
Initiated: 2014-12-12
Terminated: 2015-10-29
Firm location: Canton, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K830556 — CREATININEPointe Scientific, Inc.,·cleared 1983-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.