FDA recall Z-1407-2021

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.

Reason for recall

Possible false negative or false positive results due to the product being compromised during shipment.

Distribution

US Nationwide distribution in the state of Ohio.

Key facts

Status

Ongoing

Initiation date

2021-03-15

Report date

2021-04-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1407-2021