Diagnostica Stago Recalls Staclot LA Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA test kits because some results showed shortened times, potentially affecting lupus anticoagulant detection accuracy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, serious injuries, or deaths. The hazard is limited to potential diagnostic inaccuracy (shortened results), which fits the criteria for a moderate severity recall involving low-risk contamination or minor functional issues without reported harm.
Plain-English summary
Diagnostica Stago, Inc. is recalling 22,342 units of Staclot LA (REF 00600) test kits. These reagent systems are designed for the qualitative detection of lupus anticoagulants in plasma. The affected lots are #251918 and #252751, which were distributed nationwide in the United States.
The recall was initiated due to reports of shortened (T1-T2) results, where some instances showed result recovery outside the expected range of less than or equal to 15 seconds. This variability may impact the accuracy of the qualitative detection of lupus anticoagulants.
Healthcare professionals and laboratories using these kits should stop using the affected lots immediately. Users should contact Diagnostica Stago, Inc. for further instructions on returning or disposing of the product.
The recalled product
- Product
- 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 phospholipid molecules (1, 2).
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
- Affected units
- 22,342
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #s 251918
- 252751
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Diagnostica Stago, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Diagnostica Stago, Inc.
See all →- ModerateDiagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift
FDA (Devices) · 2026-09-09
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighStago free protein S assay may underestimate normal range results
FDA (Devices) · 2026-03-11
- HighLucky Ice mouthwash recalled over insanitary conditions at a distribution center
FDA (Devices) · 2026-01-21
- HighD-Dimer test reagents recalled over potential underestimation of measured levels
FDA (Devices) · 2025-10-22
Same hazard · diagnostic inaccuracy
See all →- High
- HighAtellica CH Enzymatic Hemoglobin A1c assay well-to-well bias
FDA (Devices) · 2026-07-15
- HighTBS iNsight bone density software calculation variability on Hologic machines
FDA (Devices) · 2025-03-12
- HighBD PCR Cartridges for MAX System signal drift in select lots
FDA (Devices) · 2025-01-29
- HighHPV-16 Diagnostic Probe Recalled for Suboptimal DNA Hybridization
FDA (Devices) · 2024-12-04
Similar recalls
- ModerateDiagnostica Stago Recalls LIATEST VWF:Ag Coagulation Assay Kits
FDA (Devices) · 2013-03-20
- ModerateDiagnostica Stago Recalls STA Staclot Protein S Reagent Due to QC Drift
FDA (Devices) · 2026-09-09
- LowStago IVD Liquid Anti-Xa Recalled for Barcode Misreading
FDA (Devices) · 2014-09-24
- HighSTA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results
FDA (Devices) · 2023-05-17
- ModerateDiagnostica Stago STA Satellite Analyzer Recalled for Incorrect INR Printouts
FDA (Devices) · 2012-11-14
- HighSTA Compact Max analyzer firmware bug causes inaccurate test results
FDA (Devices) · 2023-05-17