FDAClass IIApril 21, 2021

Diluent recall

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…

Why was Diluent recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Medline Industries Inc
Quantity
24 each
Distribution
US Nationwide distribution in the state of Ohio.
Recall date
April 21, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls