Recall Z-0741-2020
Polymer Technology Systems, Inc. · initiated March 15, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Codes / lots: Lot Number I502, UDI 00381932412018
Reason for recall
This lot of test strips is showing an under-recovery when tested against a reference method.
FDA-determined cause: Storage
Action taken
Customer Notification Letters dated 3/15/16 was sent to customers. Distributors were instructed to do the following: We need your assistance to communicate this information to any customers to whom you have shipped this specific lot of product. As per Quality System Regulations, you must have full traceability of medical product to the end-user. Please advise your customers to complete the Customer Acknowledgement and Notification Form so that PTS Diagnostics can document that they have received the notification. Upon receipt of the acknowledgement, PTS Diagnostics will provide replacements for any product which has not been consumed. Customers with any of this product remaining in their possession must Immediately discontinue use and dispose of their remaining inventory of PTS Panels CHOL+HOL+GLU test strips, lot number 1502. No other lots of this product or other PTS Diagnostics products are impacted by this action. PTS Diagnostics will provide appropriate replacement product for any product properly identified on the attached Customer Acknowledgement and Confirmation Form. Please immediately identify the number of remaining PTS Panels CHOL+HDL+GLU test strip vials you currently have remaining in inventory of lot 1502 on the attached form. We will supply you with replacement product for any unused inventory you have of this product and lot. Please return your completed form to PTS Diagnostics via fax at +1-317-870-5608 or via email at customerservice@ptsdiagnostics.com. Customers were instructed to do the following: Customers with any of this product remaining in their possession must Immediately discontinue use and dispose of their remaining inventory of PTS Panels CHOL+HOL+GLU test strips, lot number 1502. No other lots of this product or other PTS Diagnostics products are impacted by this action. PTS Diagnostics will provide appropriate replacement product for any product properly identified on the attached Customer Acknowledgement and Confir
Details
- Recall number
- Z-0741-2020
- Initiated
- March 15, 2016
- Terminated
- June 5, 2020
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Quantity
- 6467
- Distribution
- The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.
- Recalling firm
- Polymer Technology Systems, Inc., Indianapolis, IN