Reported Jul 4, 2012 · Terminated
PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood.…
Polymer Technology Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymer Technology Systems, Inc. · 7736 Zionsville Rd · Indianapolis, IN · 46268-2175
Is this the product you have?
- 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
- Lot codes and dates
Cat No. 1720and Lot number F103
- Amount recalled
- 1650 vials
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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