On October 21, 2026, the Food and Drug Administration announced a Class I recall of medical devices from Instrumentation Laboratory. The recall, which began on September 3, 2026, affects the HemoslL AcuStar HIT-lgG(PF-4) in vitro diagnostic devices due to a potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

The recall includes devices distributed worldwide, including states such as AR, CA, and NY, as well as countries like Germany, Japan, and the United Kingdom. Details can be found in the FDA's weekly enforcement report here.

Press Release: Food and Drug Administration

Published October 21, 2026. Reproduced in full from the Food and Drug Administration.

Instrumentation Laboratory medical device recall

  • Recalling company: Instrumentation Laboratory
  • Classification: Class I (the most serious type)
  • Recall numbers: Z-0001-2027, Z-0002-2027
  • Status: Ongoing
  • 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.
  • Recall started: September 3, 2026

What was recalled

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

HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic

Why

Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.

This medical device recall appears in the FDA's weekly enforcement report. Details: FDA recall event 99843.