Pointe Scientific, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2773-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: December 12, 2014

Date Posted: September 23, 2015

Recall Number: Z-2773-2015

Event ID: 71974

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.

Status: Terminated

Product Quantity: 93 kits

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated