CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
PTS Panels, Glucose Test Strips for use recalled
Polymer Technology Systems is recalling PTS Panels, Glucose Test Strips for use with CardioChek Brand Analyzers, distributed nationwide in the US. The recall was initiated on 4 Apr 2013 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-1403-2013
- FDA event ID
- 65067
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Brand
- CardioChek
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Apr 2013
- FDA classified
- 24 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 4 Apr 2013 | Recall initiated by company | |
| 24 May 2013 | Classified by FDA | +50 days |
| 5 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Product as listed by the FDA
PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
Where it was distributed
Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
Questions about this recall
Why was it recalled?
Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk.
Which lots are affected?
U1117
Where was it sold?
Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: UK, CHL, ENG, BEL, ITA, TKY, BEL, LIT, LTV, EGY, SPG, HOK, SWE, MEX, UAE, COR, ISR, MAL, AUS, POR, POL, SLN and STQ.
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.
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
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|---|---|---|---|---|---|
| Device | CLASS II | MiniMed Flex Insulin Pump recalled by Medtronic MiniMed | Medtronic MiniMed | Labeling Errors | Nationwide |
| 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 |