Recall Z-1068-2018
Diagnostica Stago, Inc. · initiated October 25, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STA - Neoplastine Cl (ref. 00605) Product Usage: Manual or automated determination of the prothrombin time (PT).
Codes / lots: Lot 251064 (Exp: 09-2018) Lot 251725 (Exp: 02-2019)
Reason for recall
Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).
FDA-determined 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).
Details
- Recall number
- Z-1068-2018
- Initiated
- October 25, 2017
- Terminated
- May 12, 2020
- Product code
- GJS – Test, Time, Prothrombin
- Distribution
- Nationally
- Recalling firm
- Diagnostica Stago, Inc., Parsippany, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1066-2018 Class II | Neoplastine Cl Plus @ (ref.00374) Product Usage: Manual or automated determination of…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | 10/25/2017Terminated |
| Z-1067-2018 Class II | Neoplastine Cl Plus (ref. 00375) Product Usage: Manual or automated determination of the…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | 10/25/2017Terminated |
| Z-1069-2018 Class II | STA - Neoplastine Cl Plus (ref. 00606) Product Usage: Manual or automated determination…Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%). | 10/25/2017Terminated |