Z-1407-2021Class II

Diluent, Stat-Site B-HB, 6x 3ML -

Name: Z-1407-2021 Diluent, Stat-Site B-HB, 6x 3ML -
Creator: Medline Industries Inc
Published: 2021-03-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2021-03-15 / Open, Classified

FDA source

Medline Industries Inc began a recall of 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... on 2021-03-15. FDA classified it as Class II and gives the reason as "Possible false negative or false positive results due to the product being compromised during shipment". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1407-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-15
Posted: 2021-04-09
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: JIN Nitroprusside, Ketones (Urinary, Non-Quant.)
Reason for recall: Possible false negative or false positive results due to the product being compromised during shipment.
FDA root cause: Storage
Action: 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.
Quantity in commerce: 24 each
Distribution: US Nationwide distribution in the state of Ohio.
Product codes and lots: Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1407-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1407-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-21	2021-04-09

Product code JIN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)