Is Instrumentation Laboratory recalled?

Yes — a recall has been published. Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

SeriousFDAOngoing

Can cause serious harm or death.

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)

Check the device or its packaging for

Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).

Why: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
Distributed: 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.
Company: Instrumentation Laboratory
Announced: 21 October 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 3 September 2026

Source: FDA record Z-0002-2027 · retrieved 9 October 2026

Every recall is shown word for word from the FDA and USDA, with a link to the source.