Z-1371-2019 Class II Terminated
FDA device recall Z-1371-2019 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
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
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
P832