Z-0002-2027

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

Name: Z-0002-2027 HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Creator: Instrumentation Laboratory
Published: 2026-09-03
License: https://open.fda.gov/license/

Instrumentation Laboratory / initiated 2026-09-03 / Open, Classified

FDA source

Recall record

Recall number: Z-0002-2027
Status: Open, Classified
Initiated: 2026-09-03
Posted: 2026-10-10
Recalling firm: Instrumentation Laboratory
Product: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Product code: LCO Platelet Factor 4 Radioimmunoassay
Reason for recall: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 1,414 units
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 codes and lots: Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).

Product code LCO

K170854Class IIHemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO / cleared 2017-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-13. View this recall on fda.gov (opens on fda.gov)