HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Summary
The FDA issued a Class I for HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic by Instrumentation Laboratory. Reason: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples..
Details
Source
Device Recall
External ID
Z-0001-2027
Action Date
2026-10-21
Status
Ongoing
Category
device
Product Description
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Lot/Code Info: Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).
Quantity Affected: 434 units
Reason for Recall
Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-03
Company
Bedford, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 150 device recalls issued in the same week, part of 446 device-related FDA actions this month.
Instrumentation Laboratory has 46 FDA actions in our database, including 45 recalls and 1 clearance.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 46 FDA actions in our database, including 45 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0001-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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