Medline Industries Inc: Medical Device Recall in 2021 - (Recall #: Z-1407-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: March 15, 2021

Date Posted: April 21, 2021

Recall Number: Z-1407-2021

Event ID: 87561

Reason for Recall:

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

Status: Ongoing

Product Quantity: 24 each

Code Information:

Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

Distribution Pattern:

US Nationwide distribution in the state of Ohio.

Voluntary or Mandated:

Voluntary: Firm initiated