Diagnostica Stago recalls Neoplastine Cl Plus reagent vials with potential for prolonged prothrombin time (PT) due to homogeneity defect. Affected lots: 115080 (exp 01/2018) and 251241 (exp 01/2018).
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Diagnostica Stago is recalling Neoplastine Cl Plus reagent vials that may give prolonged prothrombin time results. This defect could lead to inaccurate blood clotting tests, which might affect treatment decisions if not corrected.
The reagent vials have a defect in homogeneity, meaning some vials may produce prolonged prothrombin time (PT) results. This can cause inaccurate blood clotting tests, potentially leading to incorrect treatment decisions if the test is used without correction.
Users of blood clotting tests who purchased Neoplastine Cl Plus reagent vials with lot numbers 115080 or 251241 (expired January 2018) are affected. Healthcare professionals using these reagents for prothrombin time testing are most at risk.
Check the lot number on the vial label. Affected lots are 115080 (expires January 2018) and 251241 (expires January 2018).
Look for lot numbers 115080 or 251241 on the vial label.
The reagent vials may give prolonged prothrombin time (PT) results due to a homogeneity defect, which could lead to inaccurate blood clotting tests and potentially incorrect treatment decisions.
Check the lot number on the vial label. Affected lots are 115080 (expires January 2018) and 251241 (expires January 2018).
The recall does not specify a stop-use action; users should check the lot number and avoid using affected lots.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1066-2018 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-1066-2018 from Diagnostica Stago. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
