PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood.
FDA device recall Z-1903-2012 · posted 2012-06-28 · Terminated
Recall details
- Recalling firm
- Polymer Technology Systems, Inc.
- 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.
- Action taken
- 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 )
- Root cause
- Software design
- Status
- Terminated
- Product code
- JFY
- Quantity affected
- 1650 vials
- Distribution
- Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.
- Date initiated
- 2012-05-15
- Date posted
- 2012-06-28
- Date terminated
- 2012-07-20
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOSCANNER CREATININE TEST STRIPS (K010456) | Polymer Technology Systems, Inc. | 2001-06-20 |