Z-1373-2019 Class II Terminated
FDA device recall Z-1373-2019 was initiated by Polymer Technology Systems, Inc. on January 16, 2019 and is designated Class II. Reason for recall: 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 The recall status is terminated (terminated June 24, 2020). Affected quantity: 67643 total.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2019
- Initiation Date
- January 16, 2019
- Termination Date
- June 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67643 total
Product Description
CHOL+HDL+GLU test strips, REF 2412
Reason for Recall
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
Distribution Pattern
Domestic distribution nationwide.
Code Information
I808 I809 I811 I812 I814