Drug recall
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random…
FDA recall event 62894 · Class II · Instrumentation Laboratory Co.
Key facts
| Event ID | 62894 |
|---|---|
| Recall numbers | Z-2387-2012, Z-2388-2012, Z-2389-2012, Z-2390-2012, Z-2391-2012, Z-2392-2012 |
| Recalling firm | Instrumentation Laboratory Co. |
| Product type | Devices |
| Products | Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis…, Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis…, Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis…, 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…, Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis… and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low |
| Initiation date | Aug 3, 2012 |
| Report date | Sep 26, 2012 |
| Termination date | Oct 2, 2015 |
| City | Bedford |
| State | MA |
| Country | United States |
| FEI number | 1217183 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: