—#186276

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.

FDA product code: JIN — Nitroprusside, Ketones (Urinary, Non-Quant.)
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

Why it was recalled

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

Root cause (FDA determination)

Storage

Action the firm took

The firm sent an Urgent Recall Notification to its customers on 3/15/21 with the following instructions: 1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication.

Recalling firm

Firm: Medline Industries Inc
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution in the state of Ohio.

Timeline

Recall initiated: 2021-03-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186276. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.