Reported Mar 21, 2018 · Terminated
STA - Neoplastine¿ Cl Plus ¿ (ref. 00606) 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?
- STA - Neoplastine¿ Cl Plus ¿ (ref. 00606)
- Product UsageManual or automated determination of the prothrombin time (PT)
- Lot codes and dates
8 of 8 products
Products covered by this recall # Product as published 1 Lot: 250041RX (Exp: 2018-02) 2 Lot: 250077 (Exp: 2018-02) 3 Lot: 250246RU (Exp: 2018-03) 4 Lot: 251492 (Exp: 2018-09) 5 Lot: 251308 (Exp: 2018-10) 6 Lot: 251626 (Exp: 20 19-01) 7 Lot: 251730 (Exp: 2019-02) 8 Lot: 251772 (Exp: 2019-02)
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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