Diluent — Class II medical device recall Z-1407-2021
Ongoing recall by Medline Industries Inc, reported 2021-04-21, distributed nationwide. Possible false negative or false positive results due to the product being compromised during shipment.
| Recall number | Z-1407-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2021-03-15 |
| Classified | 2021-04-09 |
| Reported by FDA | 2021-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 24 units |
| Lot numbers | 160795, 163878, 191991, 192821 |
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 for recall
Possible false negative or false positive results due to the product being compromised during shipment.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1407-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.