- Recalling firm
- Instrumentation Laboratory
- Reason for recall
- Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
- Affected products (lot / model / serial)
- Part Number: 0009800127. UDI-DI: 08426951126545. Lot Number (Expiration Date): B40005 (01/16/2027), B38062 (11/01/2026).
- Units affected
- 434 units
- Distribution pattern
- 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.
- Firm location
- Bedford, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0001-2027
- Recall initiated
- September 3, 2026
- FDA classification date
- October 9, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99843
- Last updated on HTM Vibe
- October 27, 2026
