Device product
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Z-1407-2021
Product summary
- Event
- Event 87561
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 each
- Official record key
device-enforcement:Z-1407-2021
Official wording
Reason: Possible false negative or false positive results due to the product being compromised during shipment.
Code information: Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000
Distribution pattern: US Nationwide distribution in the state of Ohio.
Derived failure modes
-
Unknown
Possible false negative or false positive results due to the product being compromised during shipment.