Class III — Polymer Technology Systems, Inc.
| Recalling firm | POLYMER TECHNOLOGY SYSTEMS, INC. |
|---|---|
| Registered facility | Polymer Technology Systems (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | 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 | Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips Ref Number: 570-0414 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… |
| Quantity | 559 vials |
| Distribution | Worldwide Distribution - US Nationwide Bahamas Belgium Bermuda Brazil England Indonesia Latvia Mexico Nigeria Puerto Rico South Africa Sweden Taiwan |
| Initiated | 2019-06-07 |
| Classified | 2019-08-05 |
| Terminated | 2020-07-08 |
| Recall number | Z-2158-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Polymer Technology Systems, Inc. (Z-2158-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83097/
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