STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination of the prothrombin time (PT).
- Company
- Diagnostica Stago, Inc.
- Recall Initiated
- October 25, 2017
- Terminated
- May 12, 2020
- Recall Number
- Z-1069-2018
- Firm Location
- Parsippany, NJ
Reason for Recall
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
Distribution
Nationally
Lot / Code Info
Lot: 250041RX (Exp: 2018-02) Lot: 250077 (Exp: 2018-02) Lot: 250246RU (Exp: 2018-03) Lot: 251492 (Exp: 2018-09) Lot: 251308 (Exp: 2018-10) Lot: 251626 (Exp: 20 19-01) Lot: 251730 (Exp: 2019-02) Lot: 251772 (Exp: 2019-02)
Root Cause
Device Design
Action Taken
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).