- Recalling firm
- Magellan Diagnostics, Inc.
- Reason for recall
- In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results.
- Affected products (lot / model / serial)
- Model/Catalog Number: 70-6762. UD-DI: 00850355006000. Lot Number. 2530M-01.
- Units affected
- 321 units
- Distribution pattern
- US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY.
- Firm location
- North Billerica, 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-0162-2027
- Recall initiated
- September 4, 2026
- FDA classification date
- October 15, 2026
- FDA report date
- October 21, 2026
- FDA event ID
- 99776
- Last updated on HTM Vibe
- October 27, 2026
