- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Affected products (lot / model / serial)
- UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
- Units affected
- 5220 units
- Distribution pattern
- US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.
- Firm location
- Parsippany, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3047-2026
- Recall initiated
- July 29, 2026
- FDA classification date
- August 28, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99531
- Last updated on HTM Vibe
- September 15, 2026