FDA Recall
Terminated
STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Recall: Z-1068-2018
·
Initiated October 25, 2017
Recall
- Recall Number
- Z-1068-2018
- Event Number
- 79292
- Firm
- Diagnostica Stago, Inc.
- FEI Number
- 2245451
- Product Code
- GJS
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- October 25, 2017
- Terminated
- May 12, 2020
- Address
- 5 Century Dr, Parsippany, NJ, 07054-4607
Description
STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Reason
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Action
Stago sent an Urgent Field Safety Notice letter dated October 25, 2017 to their customers. The letter identified the affected product, problem and actions to be taken: Customers were instructed to: If it is not already done, run a Quality Control test at every change of vial (if you have affected lots of product). Return to company, by fax or email, an acknowledgement form confirming that the recall letter was read by the receiving company. For questions contact the Stago Hotline (1-800-725-0607).
Distribution
Nationally