Diagnostica Stago Recalls Staclot LA 20 Test Kits Due to Result Variability
Diagnostica Stago is recalling Staclot LA 20 test kits because some results showed shortened times outside the expected range.
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, and the source describes a performance defect (result variability) without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Diagnostica Stago, Inc. is recalling 22,342 units of Staclot LA 20 (REF 00594) test kits. These reagent systems are designed for the qualitative detection of lupus anticoagulants in plasma. The affected lots are 251504, 251916, 252243, 252364, 252887, and 253211, which were distributed nationwide in the United States.
The recall was initiated due to reports of shortened (T1-T2) results, where some instances of result recovery occurred outside the range of less than or equal to 15 seconds. This variability may affect the accuracy of the qualitative detection of lupus anticoagulants.
Healthcare facilities and laboratories that have purchased or received these specific lots should stop using the affected test kits and contact Diagnostica Stago, Inc. for further instructions or a return.
The recalled product
- 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).
- 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 (6)
- Lot #s 251504
- 251916
- 252243
- 252364
- 252887
- 253211
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.
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