Device product

CHOL+HDL+GLU test strips, REF 2412

Z-1373-2019

January 16, 2019

Class II

Product summary

Firm: Polymer Technology Systems, Inc.
Event: Event 82331
Status: Terminated
Classification: Class II
Quantity: 67643 total
Official record key: device-enforcement:Z-1373-2019

Official wording

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

Code information: I808 I809 I811 I812 I814

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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