CLASS III Device recall · Reported 14 Aug 2019 · FDA Enforcement Report
PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips recalled
Polymer Technology Systems is recalling PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips, distributed nationwide in the US. The recall was initiated on 7 Jun 2019 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-2157-2019
- FDA event ID
- 83097
- Recalling firm
- Polymer Technology Systems, Indianapolis, IN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Jun 2019
- FDA classified
- 5 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 7 Jun 2019 | Recall initiated by company | |
| 5 Aug 2019 | Classified by FDA | +59 days |
| 14 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Product as listed by the FDA
PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 1710 Product Usage: PTS Panels Lipid Panel test strips measure total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in whole blood with the CardioChek PA or the CardioChek Plus professional analyzers, and provide a quantitative result. A TC/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol are calculated by the CardioChek PA and CardioChek Plus analyzers. A MEMo Chip¿ is provided with each package of test strips and must be properly inserted into the analyzer before any test can be run. The MEMo Chip contains the test name, calibration curve, lot number and test strip expiration date. After the test strip is inserted into the analyzer and blood applied to the test strip, test results are displayed in as little as 90 seconds.
Where it was distributed
Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
Questions about this recall
Why was it recalled?
The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901
Which lots are affected?
Lot Number: P901 Exp. Date: 8/17/2020 (01) 00381931710016 (17) 200817 (10) P901
Where was it sold?
Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan
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.
Other products in this recall event
1 other product · FDA event 83097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Henry Schein Panels Lipid Panel test strip recalled | Polymer Technology Systems | Labeling Errors | 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 467| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |