- Recalling firm
- Instrumentation Laboratory
- Reason for recall
- Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID.
- Affected products (lot / model / serial)
- GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Argentina: GEM Premier 5000 Serial Nos.: 25100466, 24097933 and 23064897. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- Units affected
- 3
- Distribution pattern
- US Nationwide distribution.
- Firm location
- Bedford, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2826-2026
- Recall initiated
- May 8, 2026
- FDA classification date
- July 29, 2026
- FDA report date
- August 5, 2026
- FDA event ID
- 99115
- Last updated on HTM Vibe
- August 11, 2026