FDA Medical devices recall ·
HemoslL AcuStar HIT-lgG(PF-4) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0002-2027
- Date
- (initiated September 3, 2026)
- Company / brand
- Instrumentation Laboratory
180 Hartwell Rd, Bedford, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1,414 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Why was it recalled?
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
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 Korea, Luxembourg, Latvia, Netherlands, Saudi Arabia, Sweden, Singapore.
States: Arkansas Arizona California Connecticut Florida Georgia Massachusetts Maryland New Jersey New York Pennsylvania Rhode Island Tennessee Washington West Virginia
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0002-2027. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.