Recall Z-1067-2018 ยท GJS Test, Time, Prothrombin
Diagnostica Stago, Inc.
Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the prothrombin time (PT).
| Date | Oct 25, 2017 |
| Status | Terminated |
| Reason | Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). |
| Root cause | Device Design |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922040 | NEOPLASTINE CI PLUS American Bioproducts Co., Jun 23, 1992 |