Class II — Instrumentation Laboratory Co.
| Recalling firm | Instrumentation Laboratory Co. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval |
| Product | HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 |
| Quantity | 6504 kits |
| Distribution | Nationwide Distribution |
| Initiated | 2013-11-15 |
| Classified | 2013-12-16 |
| Terminated | 2014-03-25 |
| Recall number | Z-0515-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Instrumentation Laboratory Co. (Z-0515-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66894/
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