Home / Recalls / Pointe Scientific, Inc. / Z-2773-2015

Z-2773-2015 Class III Terminated

Recalled by Pointe Scientific, Inc. — Canton, MI

Recall Details

Product Type: Devices
Report Date: September 23, 2015
Initiation Date: December 12, 2014
Termination Date: October 29, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 93 kits

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.

Distribution Pattern

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

Code Information

C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03