FDA Device recall Z-0611-2019
Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus…
- FDA Device
- Class II
- terminated
- Published 2018-12-26
On 2018-12-26 the FDA classified a Class II recall of Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus… by Diagnostica Stago, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0611-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-11-14 |
| Published | 2018-12-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
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 phase phospholipid molecules (1, 2).
Reason
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.
Identifiers
| code_info | Lot #s 251504, 251916, 252243, 252364, 252887, 253211 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Diagnostica Stago
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074
FDA Device · Class II · 2026-09-09 · Diagnostica Stago - Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic
FDA Device · Class II · 2026-03-25 · Diagnostica Stago - Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The…
FDA Device · Class II · 2026-03-11 · Diagnostica Stago - Asserachrom HPIA. Model/Catalog Number: 00615
FDA Device · Class II · 2026-01-21 · Diagnostica Stago - Product: STA Liatest D-Di
FDA Device · Class II · 2025-10-22 · Diagnostica Stago
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0611-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.