Recall Z-1903-2012 ยท JFY Enzymatic Method, Creatinine
Polymer Technology Systems, Inc.
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 s
| Date | Jun 28, 2012 (initiated May 15, 2012) |
| Status | Terminated |
| Reason | 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 | 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 | 1650 vials |
| Distribution | Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010456 | BIOSCANNER CREATININE TEST STRIPS Polymer Technology Systems, Inc., Jun 20, 2001 |