CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report
CHOL+HDL+GLU test strips recalled by Polymer Technology Systems
Polymer Technology Systems is recalling CHOL+HDL+GLU test strips, distributed nationwide in the US. The recall was initiated on 16 Jan 2019 and the FDA has classified it as Class II.
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-1373-2019
- FDA event ID
- 82331
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Jan 2019
- FDA classified
- 23 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 16 Jan 2019 | Recall initiated by company | |
| 23 May 2019 | Classified by FDA | +127 days |
| 29 May 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Product as listed by the FDA
CHOL+HDL+GLU test strips, REF 2412
Where it was distributed
Domestic distribution nationwide.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
I808 I809 I811 I812 I814
Where was it sold?
Domestic distribution nationwide.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
2 other products · FDA event 82331| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Lipid Panel test strips (as a component of smart bundles) recalled | Polymer Technology Systems | Other | Nationwide | |
| CLASS II | Lipid Panel test strips recalled by Polymer Technology Systems | Polymer Technology Systems | Other | Nationwide |
More recalls from Polymer Technology Systems
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | A1CNow+ Multi-Test HbA1c System consists recalled | Polymer Technology Systems | Labeling Errors | Nationwide |
| Device | CLASS III | PTS Panels CHOL+GLU Test Strips recalled by Polymer Technology Systems | Polymer Technology Systems | Packaging Defects | Nationwide |
| Device | CLASS II | PTS Detect Cotinine recalled by Polymer Technology Systems | Polymer Technology Systems | Other | Nationwide |
| Device | CLASS II | Henry Schein CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
| Device | CLASS II | PTS Diagnostics CardioChek Plus Professional Analyzer recalled | Polymer Technology Systems | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 465| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| 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 |