Z-1407-2021 Class II Ongoing
FDA device recall Z-1407-2021 was initiated by Medline Industries Inc on March 15, 2021 and is designated Class II. Reason for recall: Possible false negative or false positive results due to the product being compromised during shipment. The recall status is ongoing. Affected quantity: 24 each.
Recall Details
- Product Type
- Devices
- Report Date
- April 21, 2021
- Initiation Date
- March 15, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 each
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.
Distribution Pattern
US Nationwide distribution in the state of Ohio.
Code Information
Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000