Z-1903-2012Class II

PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in...

Name: Z-1903-2012 PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in...
Creator: Polymer Technology Systems, Inc.
Published: 2012-05-15
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2012-05-15 / Terminated / root cause: software

FDA source

Polymer Technology Systems, Inc. began a recall of PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the... on 2012-05-15. FDA classified it as Class II and gives the reason as "During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1903-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-15
Posted: 2012-06-28
Terminated: 2012-07-20
Recalling firm: Polymer Technology Systems
Product: PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.
Root cause tag: software
FDA root cause: Software design
Action: Polymer Technology Systems, Inc sent a URGENT FIELD CORRECTION letter dated May 15, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed the customers to discontinue use and dispose of the product. PTS Inc. will provide appropriate replacement for any product that is properly identified on the attached Customer Acknowledgement and confirmation letter, If you have any questions please contact Customer Service toll-free at 1-877-870-5610, or +1-317-870-5610 ( outside the US )
Quantity in commerce: 1650 vials
Distribution: Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
Product codes and lots: Cat No. 1720; and Lot number F103

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1903-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1903-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-28

Product code JFY

K010456Class IIBioscanner Creatinine Test StripsPolymer Technology Systems, Inc. / cleared 2001-06-20

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)