Reported Mar 21, 2018 · Terminated
Neoplastine¿ Cl Plus ¿ (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
Diagnostica Stago, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnostica Stago, Inc. · 5 Century Dr · Parsippany, NJ · 07054-4607
Is this the product you have?
- Neoplastine¿ Cl Plus ¿ (ref. 00375)
- Product UsageManual or automated determination of the prothrombin time (PT)
- Lot codes and dates
- Lot 250080 (Exp02-2018)
- Lot 251762 (Exp02-2019)
- Lot 251940 (Exp12-2018)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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