Diagnostica Stago Recalls STA Neoplastine Cl Plus Reagent Due to Homogeneity Defect
Diagnostica Stago is recalling STA Neoplastine Cl Plus reagent vials due to a confirmed homogeneity defect that 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 is a defect in test accuracy (homogeneity) rather than a direct physical injury or contamination, and no illnesses or injuries are reported in the source text.
Plain-English summary
Diagnostica Stago, Inc. is recalling specific lots of STA Neoplastine Cl Plus (ref. 00606), 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 not perform consistently.
The defect may cause some vials to give prolonged Prothrombin Time results, which corresponds to decreased PT%. This inaccuracy could affect the reliability of the diagnostic tests performed using the affected reagent. The affected lots are 250041RX, 250077, 250246RU, 251492, 251308, 251626, 251730, and 251772, with expiration dates ranging from February 2018 to February 2019.
The product was distributed nationally. Users of the product should check their inventory for the affected lot numbers and stop using the product if it matches the recalled lots. They should contact Diagnostica Stago, Inc. for further instructions or a replacement.
The recalled product
- Product
- STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Manufacturer
- Diagnostica Stago, Inc.
- Hazard
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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