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U.S. Department of Health and Human Services

Class 2 Device Recall PTS Panels Creatinine test strips.

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 Class 2 Device Recall PTS Panels Creatinine test strips.see related information
Date Initiated by FirmMay 15, 2012
Date PostedJune 28, 2012
Recall Status1 Terminated 3 on July 20, 2012
Recall NumberZ-1903-2012
Recall Event ID 61966
510(K)NumberK010456 
Product Classification Enzymatic method, creatinine - Product Code JFY
ProductPTS 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
Code Information Cat No. 1720; and Lot number F103
Recalling Firm/
Manufacturer		 Polymer Technology Systems, Inc.
7736 Zionsville Rd
Indianapolis IN 46268-2175
For Additional Information Contact
317-870-5610
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionPolymer 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 in Commerce1650 vials
DistributionWorldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JFY
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