Z-0002-2027 Class I Ongoing
FDA device recall Z-0002-2027 was initiated by Instrumentation Laboratory on Sep 3, 2026 and is designated Class I. Reason for recall: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. The recall status is ongoing. Affected quantity: 1,414 units.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 21, 2026
- Initiation Date
- Sep 3, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,414 units
Product Description
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Reason for Recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Distribution Pattern
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 Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.
Code Information
Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0002-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026