Device product
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
Z-1371-2019
Product summary
- Event
- Event 82331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 67643 total
- Official record key
device-enforcement:Z-1371-2019
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: P832
Distribution pattern: Domestic distribution nationwide.
Derived failure modes
-
Unknown
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.