Medline Industries Inc Recall 87561
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.
Medline Industries Inc Recall 87561 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1407-2021 |
| Event ID | 87561 |
| Event 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Ohio. |
| Quantity | 24 each |
| Recall Reason | Possible false negative or false positive results due to the product being compromised during shipment. |
| Device Classification | 20210421 |
| Device Code Info | Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000 |
| Center Classification Date | 20210409 |
| Recall Initiation Date | 20210315 |
| Recalling Firm | Medline Industries Inc |
| Initial Notification | Letter |
| Similar To |