HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in… recallZ-0002-2027 · Instrumentation Laboratory · initiated Sep 3, 2026

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

Instrumentation Laboratory notified consignees on about 09/03/2026 via emailed and mailed URGENT MEDICAL DEVICE REALL letter. Consignees were made aware of the issue and hazard involved. They were instructed to check inventory for affected lots, destroy any remaining product following each facility's standard procedures, and document the destruction on the enclosed Urgent Mandatory Response Tracking Form, including quantity destroyed and date of destruction. Consignees were asked to identify an alternative method for HIT antibody testing as a supply interruption is expected and work local Werfen representatives for guidance and transition support. Consignees were also requested to inform all laboratory personnel of the notification, forward the notification to all affected departments and locations within each facility, retain a copy of the notification for records and complete and return the Urgent Mandatory Response Tracking Form within 10 days of receipt even if there is no remaining inventory. On 09/29/2026, an expanded URGENT MEDICAL DEVICE RECALL Notification was sent to consignees through registered mail or email. The updated notification informed consignees of additional lot numbers affected. Instructions remained the same.

Recall details

Recall number

Z-0002-2027

Recall class

Not yet classified by the FDA

Status

Open, Classified

Initiated by the company

Sep 3, 2026

Posted by the FDA

Oct 10, 2026

Recalling firm

Instrumentation Laboratory

Quantity

1,414 units

Product code

LCO

FDA submissions

K170854

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.

Product description

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

Other devices under the same FDA submission

1 device cleared under K170854 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• HemosIL AcuStar HIT-IgG (PF4-H) 0009800127

  Instrumentation Laboratory Company · PLATELET FACTOR 4 RADIOIMMUNOASSAY
  1 recall4 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 99843).

• Z-0001-2027 · Open, Classified
  HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic