Reported Sep 21, 2022 · Completed
PTS Panels CHOL+GLU Test Strips (REF 1765)
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · 4600 Anson Blvd · Whitestown, IN · 46075-4489
Is this the product you have?
- PTS Panels CHOL+GLU Test Strips (REF 1765)
- Lot codes and dates
- Complete UDI(01)00381931765016(17)230627(10)A202
- UPC Code381931765016 lot A202
Where it was sold
- Nationwide
- VA
Why it was recalled
Incorrect instructions for use were packaged into the final product.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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