Recall Z-0002-2027 ยท LCO Platelet Factor 4 Radioimmunoassay
Instrumentation Laboratory
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
| Date | Oct 10, 2026 (initiated Sep 3, 2026) |
| Status | Open, Classified |
| Reason | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| Root cause | Under Investigation by firm |
| Action | Instrumentation Laboratory notified consignees on about 09/03/2026 via emailed and mailed URGENT MEDICAL DEVICE REALL letter. Consignees were made aware of the issue and hazard involved. They were instructed to check inventory for affected lots, destroy any remaining product following each facility's standard procedures, and document the destruction on the enclosed Urgent Mandatory Response Tracking Form, including quantity destroyed and date of destruction. Consignees were asked to identify an alternative method for HIT antibody testing as a supply interruption is expected and work local We |
| Quantity | 1,414 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Kore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170854 | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls Instrumentation Laboratory CO, Sep 8, 2017 |