Drug recall
Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the…
FDA recall event 81678 · Class II · Diagnostica Stago, Inc.
Key facts
| Event ID | 81678 |
|---|---|
| Recall numbers | Z-0610-2019, Z-0611-2019 |
| Recalling firm | Diagnostica Stago, Inc. |
| Product type | Devices |
| Products | Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII…, Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| Initiation date | Nov 14, 2018 |
| Report date | Dec 26, 2018 |
| Termination date | Jun 8, 2020 |
| City | Parsippany |
| State | NJ |
| Country | United States |
| FEI number | 2245451 |
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: