CLASS III Device recall · Reported 21 Sep 2022 · FDA Enforcement Report
PTS Panels CHOL+GLU Test Strips recalled by Polymer Technology Systems
Polymer Technology Systems is recalling PTS Panels CHOL+GLU Test Strips (, distributed nationwide in the US. The recall was initiated on 16 Aug 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1741-2022
- FDA event ID
- 90791
- Recalling firm
- Polymer Technology Systems, Whitestown, IN
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 16 Aug 2022
- FDA classified
- 14 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 16 Aug 2022 | Recall initiated by company | |
| 14 Sep 2022 | Classified by FDA | +29 days |
| 21 Sep 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect instructions for use were packaged into the final product.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
PTS Panels CHOL+GLU Test Strips (REF 1765)
Where it was distributed
Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
Questions about this recall
Why was it recalled?
Incorrect instructions for use were packaged into the final product.
Which lots are affected?
Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
Where was it sold?
Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
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