Diagnostica Stago Recalls STA Neoplastine Cl Reagent Due to Homogeneity Defect
Diagnostica Stago, Inc. is recalling STA Neoplastine Cl reagent vials because a homogeneity defect may cause inaccurate prothrombin time test results.
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. The hazard involves inaccurate test results due to a homogeneity defect, but the source text does not report any hospitalizations, serious injuries, or deaths, placing it in the Moderate category per the rubric.
Plain-English summary
Diagnostica Stago, Inc. is voluntarily recalling specific lots of STA Neoplastine Cl reagent (reference 00605). This product is used for the manual or automated determination of prothrombin time (PT). The recall is due to a confirmed defect of homogeneity, which means that some reagent vials may not perform consistently.
The affected lots are Lot 251064 (expiration date 09-2018) and Lot 251725 (expiration date 02-2019). The defect may cause some vials to give prolonged Prothrombin Time results, which corresponds to decreased PT%. This could lead to inaccurate diagnostic testing.
The product was distributed nationally. Users of this reagent should stop using the affected lots and contact Diagnostica Stago, Inc. for further instructions or replacement.
The recalled product
- Product
- STA - Neoplastine¿ Cl ¿ (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Manufacturer
- Diagnostica Stago, Inc.
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 (1)
- Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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