FDA Medical Device Recalls (openFDA)
Medline Industries Inc: 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.
- Recall number
- Z-1407-2021
- Recalling firm
- Medline Industries Inc
- 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.
- Status
- Open, Classified
- Initiated
- 2021-03-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- Possible false negative or false positive results due to the product being compromised during shipment.
- 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
- 24 each
- Distribution
- US Nationwide distribution in the state of Ohio.
- Lot, serial or model codes
- Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIN
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28