Diagnostica Stago Recalls Neoplastine Cl Plus Reagent Due to Homogeneity Defect
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials because a 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm through inaccurate diagnostic results (prolonged PT), which fits the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Diagnostica Stago, Inc. is recalling Neoplastine Cl Plus (ref. 00375), a reagent used for the manual or automated determination of prothrombin time (PT). The recall involves specific lots: 250080 (Exp: 02-2018), 251762 (Exp: 02-2019), and 251940 (Exp: 12-2018). The product was distributed nationally.
The recall was initiated due to a confirmed defect of homogeneity. This defect may cause some reagent vials to yield prolonged Prothrombin Time results, which corresponds to decreased PT% values. Inaccurate PT results can affect clinical decision-making regarding anticoagulant therapy.
Healthcare facilities and laboratories should stop using the affected lots and contact Diagnostica Stago, Inc. for further instructions or replacement. Consumers should not use these specific lots for testing.
The recalled product
- Product
- Neoplastine¿ Cl Plus ¿ (ref. 00375) 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 250080 (Exp: 02-2018) Lot 251762 (Exp: 02-2019) Lot 251940 (Exp: 12-2018)
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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