HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 — Class II medical device recall Z-0516-2014
Terminated recall by Instrumentation Laboratory Co., reported 2013-12-25, distributed nationwide. HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
| Recall number | Z-0516-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory Co., Bedford, MA, United States |
| Recall initiated | 2013-11-15 |
| Classified | 2013-12-16 |
| Reported by FDA | 2013-12-25 |
| Terminated | 2014-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 84,561 kits |
| Model numbers | 0020003320 |
Product
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Reason for recall
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
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-0516-2014. 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.