PTS Panels CHOL+GLU Test Strips (REF 1765) recallZ-1741-2022 · Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · initiated Aug 16, 2022
Completed
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Incorrect instructions for use were packaged into the final product.
FDA root cause category: Labeling Change Control
What the company is doing
PTS 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).
Recall details
- Recall number
- Z-1741-2022
- Status
- Completed
- Initiated by the company
- Aug 16, 2022
- Recalling firm
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Product code
- CGA
- FDA submissions
- K162282
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Product description
PTS Panels CHOL+GLU Test Strips (REF 1765)
Code information (models, lots, serial numbers)
Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- PTS Panels® CHOL+Glu Test Strips 1765Polymer Technology Systems, Inc. · ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL2 recalls3 reports
Other devices under the same FDA submission
1 device cleared under K162282 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- PTS Panels® CHOL+HDL+GLU Test Strips 2412Polymer Technology Systems, Inc. · GLUCOSE OXIDASE, GLUCOSE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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