PTS Panels® CHOL+HDL+GLU Test Strips 2412Recalls & reported problems
Polymer Technology Systems, Inc. · PTS Panels® CHOL+HDL+GLU test strips are in vitro diagnostic devices used to monitor total cholesterol; HDL Cholesterol and glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K162282); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Mar 15, 2016Class IITerminated
This lot of test strips is showing an under-recovery when tested against a reference method.
Z-0741-2020 · Root cause: Storage · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K162282. One submission often covers many models, so check the product and lot details in each record.
- Z-1741-2022 · Aug 16, 2022 · CompletedPTS Panels CHOL+GLU Test Strips (REF 1765)
Other GLUCOSE OXIDASE, GLUCOSE devices
- TRUEtrack TRUEtrack 50 Blood Glucose Test StripsTrividia Health, Inc. · Glucose Oxidase, Glucose153 reports
- HemoCue® Glucose 201 Microcuvettes 110706Hemocue AB · Glucose Oxidase, Glucose2 recalls0 reports
- VITROS 1707801Ortho-Clinical Diagnostics, Inc. · GLUCOSE OXIDASE, GLUCOSE1 recall48 reports
- Prodigy AutoCode Blood Glucose Monitoring System 051885Prodigy Diabetes Care, LLC · Glucose Oxidase, Glucose93 reports
- OneTouch Ultra Blue 022-895LifeScan U.S. LLC · GLUCOSE OXIDASE, GLUCOSE1 recall7 reports
- OneTouch Ultra Blue 020-994LifeScan U.S. LLC · GLUCOSE OXIDASE, GLUCOSE1 recall2 reports
- Alere Cholestech LDX® 10-991Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall1 report
- Cholestech LDX™ 97991Alere San Diego, Inc. · Glucose Oxidase, Glucose1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page