Diagnostica Stago Recalls Neoplastine Cl Plus Prothrombin Time Reagent Kits
Diagnostica Stago is recalling 1,636 Neoplastine Cl Plus kits due to a defect causing 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, and the defect poses a risk of harm through inaccurate diagnostic results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Diagnostica Stago, Inc. is recalling 1,636 kits of Neoplastine Cl Plus (ref.00374), a reagent 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 yield prolonged prothrombin time results, indicated by a decreased PT percentage.
The affected products are distributed nationally and include Lot 115080 (Expiration: 01-2018) and Lot 251241 (Expiration: 01-2018). This defect may lead to inaccurate laboratory test results for patients undergoing prothrombin time testing.
Healthcare facilities and laboratories should stop using the affected lots and contact the manufacturer for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Manufacturer
- Diagnostica Stago, Inc.
- Affected units
- 1,636
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 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)
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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