FDA Device recall Z-0741-2020
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
- FDA Device
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers by Polymer Technology Systems, citing this lot of test strips is showing an under-recovery when tested against a reference method.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0741-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-03-15 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Polymer Technology Systems |
| Distribution | CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, WI |
Product
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Reason
This lot of test strips is showing an under-recovery when tested against a reference method.
Identifiers
| code_info | Lot Number I502, UDI 00381932412018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0741-2020%22
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