PTS Panels Creatinine test strips — Class II medical device recall Z-1903-2012

Terminated recall by Polymer Technology Systems, Inc., reported 2012-07-04, distributed nationwide. During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a v

Recall number	`Z-1903-2012`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Polymer Technology Systems, Inc., Indianapolis, IN, United States
Recall initiated	2012-05-15
Classified	2012-06-28
Reported by FDA	2012-07-04
Terminated	2012-07-20
Distributed	Nationwide (US)
Countries outside the US	CN, FR, IE, PL
Quantity	1,650 vials
Reason classes	potency
Lot numbers	`F103`
Model numbers	`1720`

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1903-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.