Class 1 Device Recall HemoslL AcuStar HITlgG(PF4)

• Date Initiated by Firm: September 03, 2026
• Date Posted: October 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0002-2027
• Recall Event ID: 99843
• 510(K)Number: K170854
• Product Classification: Platelet factor 4 radioimmunoassay - Product Code LCO
• Product: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
• Code Information: Part Number: 0009802028. UDI-DI: 08426950545774. Lot Number (Expiration Date): B40006 (01/16/2027), B38063 (11/01/2026).
• FEI Number: 1217183
• Recalling Firm/ Manufacturer: Instrumentation Laboratory; 180 Hartwell Rd; Bedford MA 01730-2443
• For Additional Information Contact: Keith Kelly; 732-3792123
• Manufacturer Reason for Recall: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LCO