FDAFDA · Food and drugs·Recall number Z-1373-2019
CHOL+HDL+GLU test strips, REF 2412
Published May 29, 2019 · Recall initiated: January 16, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Polymer Technology Systems, Inc.
- Distributor
- Domestic distribution nationwide.
- Lot
- I808 I809 I811 I812 I814
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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