Staclot LA 20 — Class II medical device recall Z-0611-2019
Terminated recall by Diagnostica Stago, Inc., reported 2018-12-26, distributed nationwide. There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the r
| Recall number | Z-0611-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2018-11-14 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 22,342 total |
| Lot numbers | 251504, 251916, 252243, 252364, 252887, 253211 |
| Model numbers | 00594 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0611-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.