Diagnostica Stago recalls Neoplastine Cl reagent vials with potential for prolonged prothrombin time (PT) due to homogeneity defects. Affected lots: 251064 (exp 09/2018) and 251725 (exp 02/2019).
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Diagnostica Stago recalls Neoplastine Cl reagent vials that may give prolonged prothrombin time results. This defect could lead to inaccurate blood clotting tests, potentially causing unsafe bleeding or clotting. Affected vials have specific lot numbers and expiration dates.
The reagent vials have a defect causing inconsistent homogeneity, which may result in prolonged prothrombin time (PT) readings. This can lead to inaccurate blood clotting test results, potentially causing unsafe bleeding or clotting if used in medical procedures.
Healthcare professionals using blood clotting tests with Neoplastine Cl reagents. Those who use the affected lot numbers (251064 or 251725) are most at risk.
Check the lot number on the vial label: 251064 (expires 09/2018) or 251725 (expires 02/2019). The product is used for manual or automated prothrombin time (PT) testing.
Look for lot numbers 251064 (expires 09/2018) or 251725 (expires 02/2019) on the reagent vial label.
The recall is due to a confirmed defect of homogeneity where some reagent vials may give prolonged prothrombin time (PT) results, potentially causing inaccurate blood clotting tests.
Check the lot number on the vial label. If it matches 251064 (expires 09/2018) or 251725 (expires 02/2019), contact Diagnostica Stago for instructions.
The recall record does not specify a remedy; affected users should check with Diagnostica Stago for guidance.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1068-2018 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-1068-2018 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.
