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U.S. Department of Health and Human Services

Class 3 Device Recall PTS Panels CHOLGLU Test Strips

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 Class 3 Device Recall PTS Panels CHOLGLU Test Stripssee related information
Date Initiated by FirmAugust 16, 2022
Create DateSeptember 14, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1741-2022
Recall Event ID 90791
510(K)NumberK162282 
Product Classification Glucose oxidase, glucose - Product Code CGA
ProductPTS Panels CHOL+GLU Test Strips (REF 1765)
Code Information Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
Recalling Firm/
Manufacturer		 Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
4600 Anson Blvd
Whitestown IN 46075-4489
For Additional Information ContactPTS Diagnostics Customer Service
877-570-8610
Manufacturer Reason
for Recall		Incorrect instructions for use were packaged into the final product.
FDA Determined
Cause 2		Labeling Change Control
ActionPTS Diagnostics notified customers on August 16, 2022, through an Urgent Medical Device Recall letter. Customers were instructed to return product for replacement. Distributors were asked to forward the notice to all customers/users who may have received the product. If you have any questions, please contact PTS Diagnostics' Customer Service directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at +1 317-870-5610 or 877-570-8610 (U.S. toll-free).
DistributionWorldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CGA
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