FDA Medical Device Recalls (openFDA)
Polymer Technology Systems, Inc.: PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
- Recall number
- Z-0741-2020
- Recalling firm
- Polymer Technology Systems, Inc.
- Product
- PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
- Status
- Terminated
- Initiated
- 2016-03-15
- Posted
- not on file
- Terminated
- 2020-06-05
- Reason
- This lot of test strips is showing an under-recovery when tested against a reference method.
- Root cause
- Storage
- Action
- 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
- 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.
- Lot, serial or model codes
- Lot Number I502, UDI 00381932412018
- 510(k) numbers
- ["K071507","K162282"]
- PMA numbers
- not on file
- Product code
- NBW
- Firm FEI
- 3015525148
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28