FDA Device recall Z-2388-2012
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically…
- FDA Device
- Class II
- terminated
- Published 2012-09-26
On 2012-09-26 the FDA classified a Class II recall of Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically… by Instrumentation Laboratory, citing low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2388-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-08-03 |
| Published | 2012-09-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters
Reason
Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
Identifiers
| code_info | Serial Number range: 09080100 through12060403 Distributed between: Aug 2009 to Jun 2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2388-2012%22
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