Z-2773-2015Class III

Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one...

Name: Z-2773-2015 Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one...
Creator: Pointe Scientific, Inc.
Published: 2014-12-12
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-12-12 / Terminated / root cause: manufacturing process

FDA source

Pointe Scientific, Inc. began a recall of 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... on 2014-12-12. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2773-2015
Classification: Class III
Status: Terminated
Initiated: 2014-12-12
Posted: 2015-09-16
Terminated: 2015-10-29
Recalling firm: Horiba Instruments Incorporated
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.
Product code: CGX Alkaline Picrate, Colorimetry, Creatinine
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313.
Quantity in commerce: 93 kits
Distribution: Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
Product codes and lots: C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2773-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2773-2015	Class III	Terminated	Voluntary: Firm initiated	2015-09-23	2015-09-16

Product code CGX

K830556Class IICreatininePointe Scientific, Inc., / cleared 1983-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)