FDA Device recall Z-0515-2014
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 by Instrumentation Laboratory, citing hemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0515-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-15 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Reason
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0515-2014%22
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