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.
Reported: April 21, 2021 Initiated: March 15, 2021 #Z-1407-2021
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.
Reason for Recall
Possible false negative or false positive results due to the product being compromised during shipment.
Details
- Recalling Firm
- Medline Industries Inc
- Units Affected
- 24 each
- Distribution
- US Nationwide distribution in the state of Ohio.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medline Industries Inc. Units affected: 24 each.
Why was this product recalled? ▼
Possible false negative or false positive results due to the product being compromised during shipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1407-2021.
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