S-O303000 CONTROL — Class III medical device recall Z-1135-2021
Terminated recall by Medline Industries Inc, reported 2021-03-03, distributed nationwide. Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the m
| Recall number | Z-1135-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2021-01-15 |
| Classified | 2021-02-19 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2023-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 46 units |
| Lot numbers | 154590, 154950, 158668, 159370, 192532, 192891, 19365, 200831 |
| Serial numbers | 154590, 154950, 158668, 159370, 192532, 192891, 19365, 200831 |
| Model numbers | S-O303000 |
Product
S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended for the quantitative determination of the ketone body ¿-Hydroxybutyrate in serum or plasma. For laboratory use only.
Reason for recall
Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O303000, from the market, 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-1135-2021. 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.