Z-1066-2018 Class II Terminated
FDA device recall Z-1066-2018 was initiated by Diagnostica Stago, Inc. on October 25, 2017 and is designated Class II. Reason for recall: Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). The recall status is terminated (terminated May 12, 2020). Affected quantity: 1636 Kits.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- October 25, 2017
- Termination Date
- May 12, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1636 Kits
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%).
Distribution Pattern
Nationally
Code Information
Lot 115080 (Exp: 01-2018) Lot 251241 (Exp: 01-2018)