PTS Panels CHOL+GLU Test Strips (REF 1765)

Recall Insight

This FDA Devices action (record #Z-1741-2022) was formally reported on September 21, 2022, with the manufacturer initiating the action on August 16, 2022. It is classified under Low severity (Class III), with a current status of Completed. Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. is listed as the recalling firm, operating out of Whitestown, IN. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.

The documented reason for this recall is: Incorrect instructions for use were packaged into the final product. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.