HemosIL AcuStar HIT-IgG(PF4-H) lot recall: destroy listed lots and document on the response form
Published November 8, 2026 · Coverage November 1–7, 2026, Pacific · High priority
FDA identified as the most serious type of recall the removal of four lots of an assay that, with other laboratory and clinical findings, aids in determining the risk for heparin-induced thrombocytopenia (HIT): HemosIL AcuStar HIT-IgG(PF4-H), from Instrumentation Laboratories (Werfen). Werfen found a performance issue in lots B40005, B40006, B38062 and B38063 that may cause a negative bias, so sample results could be incorrectly reported below the assay cut-off (1.00 U/mL) and be interpreted as HIT IgG antibody negative. The earlier article reported FDA's listing of the confirmed recall on October 30, 2026, and FDA says a supply interruption is expected.
Current status
On November 10, 2026, the FDA page showed content current as of October 30, 2026, with the four listed lots and the destruction instructions, and FDA's list of recalls and early alerts showed the recall in a row dated October 30, 2026 with status Recall Confirmed.
Who this affects
Hospital laboratories running HemosIL AcuStar HIT-IgG(PF4-H)
Why it matters
A result from an affected lot incorrectly reported below the cut-off may delay recognition of HIT, and FDA says that in patients with HIT, continued exposure to heparin may increase the risk of thrombotic complications. Laboratories need an alternative HIT antibody method because a supply interruption is expected, and decisions about reviewing prior results, patient follow-up or repeat testing rest with the laboratory and/or the treating clinician.
Recommended action
- Check inventory for lots B40005, B40006, B38062, B38063 and destroy remaining product under facility procedures (FDA)
- Document destruction on the Urgent Mandatory Response Tracking Form (FDA)
- Identify an alternative HIT antibody testing method
Scope and timing
- Authority status
- Other (FDA recall)
- Responsible owner
- Laboratory, Hematology, Patient safety
- Other dates
- FDA page content current as of 2026-10-30; the earlier article gives October 30 as the recall listing date
Not established
Manufacturer letter not reviewed.
Earlier article: November 4, 2026 edition →
Sources
Complete edition and supplemental material
This article in the complete report →
Executive triage, source-coverage limitations, context and forward horizons remain in the complete report.
Read the entire Compliance Sweep report →