FDA Device recall Z-1373-2019
CHOL+HDL+GLU test strips, REF 2412
- FDA Device
- Class II
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class II recall of CHOL+HDL+GLU test strips, REF 2412 by Polymer Technology Systems, citing some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1373-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-16 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Polymer Technology Systems |
| Distribution | US |
Product
CHOL+HDL+GLU test strips, REF 2412
Reason
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed
Identifiers
| code_info | I808 I809 I811 I812 I814 |
|---|
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-1373-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.