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PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412… recallZ-0741-2020 · Polymer Technology Systems, Inc. · initiated Mar 15, 2016

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Polymer Technology Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

This lot of test strips is showing an under-recovery when tested against a reference method.

FDA root cause category: Storage

What the company is doing

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 [email protected]. 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

Recall details

Recall number
Z-0741-2020
Status
Terminated
Initiated by the company
Mar 15, 2016
Recalling firm
Polymer Technology Systems, Inc.
Quantity
6467
Product code
NBW
FDA submissions
K071507, K162282
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.

Product description

PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

Code information (models, lots, serial numbers)

Lot Number I502, UDI 00381932412018

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K071507, K162282 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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