PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref… — Class III medical device recall Z-2157-2019
Terminated recall by Polymer Technology Systems, Inc., reported 2019-08-14, distributed nationwide. The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD sc
| Recall number | Z-2157-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Polymer Technology Systems, Inc., Indianapolis, IN, United States |
| Recall initiated | 2019-06-07 |
| Classified | 2019-08-05 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, BM, BR, BS, GB, ID, LV, MX, NG, SE, TW, ZA |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00381931710016 |
| Lot numbers | P901 |
| Model numbers | 1710 |
| Expiration dates | 2020-08-17 |
Product
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.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2157-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.