Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Reported: March 21, 2018 Initiated: October 25, 2017 #Z-1066-2018
Product Description
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).
Reason for Recall
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Details
- Recalling Firm
- Diagnostica Stago, Inc.
- Units Affected
- 1636 Kits
- Distribution
- Nationally
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Neoplastine¿ Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of the prothrombin time (PT).. Recalled by Diagnostica Stago, Inc.. Units affected: 1636 Kits.
Why was this product recalled? ▼
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-1066-2018.
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