Recall Z-2473-2025 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Diagnostica Stago, Inc.
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
| Date | Aug 28, 2025 (initiated Jul 21, 2025) |
| Status | Open, Classified |
| Reason | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| Root cause | Mixed-up of materials/components |
| Action | Diagnostica Stago notified consignees on about 07/21/2025 via emailed letter titled URGENT: MEDICAL DEVICE RECALL (CORRECTION). Consignees were instructed to temporarily systematically run a quality control just before a batch of UFH or LMWH, if you run STA-LIQUID ANTI-Xa in UFH and LMWH applications on your STA SATELLITE analyzer. This request is being asked while Stago works to develop a permanent solution for the analyzer. Consignees were also requested to complete and return the Acknowledgement Form and to notify customers if affected units were transferred or further distributed. |
| Quantity | 3,650 units (538 US) |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, LA, MD, ME, MN, MO, MT, NC, OH, OK, OR, PA, PR, SD, VT, WI, WY and the countries of Algeria, Argentina, Austria, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, France, French Polynesie, Guadeloupe, India, Iran, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082248 | STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER Diagnostica Stago, Inc., Dec 12, 2008 |