PTS Panels CHOL+GLU Test Strips (REF 1765)
Summary
The FDA issued a Class III for PTS Panels CHOL+GLU Test Strips (REF 1765) by Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.. Reason: Incorrect instructions for use were packaged into the final product..
Details
Source
Device Recall
External ID
Z-1741-2022
Action Date
2022-09-21
Status
Completed
Category
device
Product Description
PTS Panels CHOL+GLU Test Strips (REF 1765)
Lot/Code Info: Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
Reason for Recall
Incorrect instructions for use were packaged into the final product.
Distribution
Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-16
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. have FDA actions?
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1741-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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