FDA Device recall Z-1407-2021
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 specim…
- FDA Device
- Class II
- ongoing
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II 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 specim… by Medline Industries, citing possible false negative or false positive results due to the product being compromised during shipment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1407-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-15 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries |
| Distribution | US |
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.
Reason
Possible false negative or false positive results due to the product being compromised during shipment.
Identifiers
| code_info | Lot #: 163878, 192821,191991, 160795 Manufacturer number:O202000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1407-2021%22
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