Recall Z-0002-2027— Instrumentation Laboratory

Name: FDA recall Z-0002-2027
Creator: U.S. Food and Drug Administration
Published: 2026-09-03

Class I · Ongoing

Class I FDA medical device recall by Instrumentation Laboratory, initiated 2026-09-03. It names one FDA 510(k) clearance: K170854. Product: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only). Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples..

Recalling firm: Instrumentation Laboratory
Classification: Class I
Status: Ongoing
Initiated: 2026-09-03
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO·cleared 2017-09-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.