Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 k...
FDA Recall #Z-2773-2015 — Class III — December 12, 2014
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.
Recalling Firm
Pointe Scientific, Inc. — Canton, MI
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
93 kits
Distribution
Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
Code Information
C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated