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

FDA Device Recall #Z-1903-2012 — Class II — May 15, 2012

Recall Summary

Recall Number Z-1903-2012
Classification Class II — Moderate risk
Date Initiated May 15, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Polymer Technology Systems, Inc.
Location Indianapolis, IN
Product Type Devices
Quantity 1650 vials

Product Description

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.

Distribution Pattern

Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.

Lot / Code Information

Cat No. 1720; and Lot number F103

Other Recalls from Polymer Technology Systems, Inc.

Recall # Classification Product Date
Z-1438-2020 Class II PTS Detect Cotinine, Ref. No. 3061, UPC 3819330... Jan 21, 2020
Z-0834-2020 Class II Henry Schein CardioChek Starter Kit, Reference ... Dec 2, 2019
Z-0832-2020 Class II PTS Diagnostics CardioChek Plus Professional An... Dec 2, 2019
Z-0833-2020 Class II PTS Diagnostics CardioChek Plus Professional An... Dec 2, 2019
Z-0835-2020 Class II Henry Schein CardioChek Plus Professional Analy... Dec 2, 2019

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.