PTS Panels Lipids Panel test strips for self-testing or… recallZ-1136-2010 · Polymer Technology Systems, Inc. · initiated Jun 5, 2009
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Polymer Technology Systems, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Exhibits under-recovery of all analytes.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Consignees were notified by letter dated 6/5/09, advised of the problem, and that the firm would replace product.
Recall details
- Recall number
- Z-1136-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 5, 2009
- Posted by the FDA
- Mar 15, 2010
- Recalling firm
- Polymer Technology Systems, Inc.
- Quantity
- Not available.
- Product code
- CHH
- FDA submissions
- K022898, K023558
- Distribution
- Nationwide and international.
Product description
PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers, Manufactured by Polymer Technology Systems, Inc. Catalog # 1710.
Code information (models, lots, serial numbers)
Lot P814; exp. 9/2/09.
Other devices under the same FDA submission
1 device cleared under K022898, K023558 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CardioChek 5700414Henry Schein, Inc. · LDL & VLDL PRECIPITATION, HDL1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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