Diagnostica Stago recalls Neoplastine Cl Plus (ref. 00375) due to reagent vials causing prolonged prothrombin time. Affected lots: 250080 (exp 02/2018), 251762 (exp 02/2019), 251940 (exp 12/2018).
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Diagnostica Stago recalls Neoplastine Cl Plus reagent vials that may cause prolonged prothrombin time (PT) results. This defect could lead to inaccurate blood clotting tests, potentially affecting medical decisions. The recall affects specific lots with expiration dates listed in the record.
The reagent vials have a defect causing some to give prolonged prothrombin time results. This means blood clotting tests may be inaccurate, potentially leading to incorrect medical decisions if used without replacement.
Users of Neoplastine Cl Plus reagent vials for prothrombin time testing are affected. Laboratory staff and healthcare providers using the recalled lots are most at risk.
Check the lot number on the vial: 250080 (expires 02/2018), 251762 (expires 02/2019), or 251940 (expires 12/2018). The product is used for manual or automated prothrombin time testing.
Identify the lot number on the vial to see if it matches 250080, 251762, or 251940.
Neoplastine Cl Plus is used for manual or automated determination of prothrombin time (PT).
Lots 250080 (expires 02/2018), 251762 (expires 02/2019), and 251940 (expires 12/2018) are affected.
The recall record states the remedy is null, meaning no specific action is required beyond checking the lot number.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1067-2018 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-1067-2018 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.
