- 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 Spain: GEM Premier 5000 Serial Nos.: 25028719, 18021546, 18021549, 26012036, 18051850, 23054764, 21068342, 25080219, 26010781, 25122012, 25041639, 25120558, 25079944, 25079943, 25028719, 25100485, 25079947, 25100483, 25100484, 21057870 and 26010710. 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
- 21
- 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-2825-2026
- 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