Z-1903-2012 Class II Terminated
FDA device recall Z-1903-2012 was initiated by Polymer Technology Systems, Inc. on May 15, 2012 and is designated Class II. 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 recall status is terminated (terminated July 20, 2012). Affected quantity: 1650 vials.
Recall Details
- Product Type
- Devices
- Report Date
- July 4, 2012
- Initiation Date
- May 15, 2012
- Termination Date
- July 20, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Cat No. 1720; and Lot number F103