TemporaryFDAOngoing
Can make you unwell for a while. Do not eat it.
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Check your package for
GEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in Hong Kong: GEM Premier 5000 Serial Nos.: 20106073, 20106039, 19052933, 20116415, 20064792, 22062065, 22062067, 19103490, 22092716, 22102881, 18112339, 19012518, 20126582, 20075256, 20064794, 20106036, 24016057, 21088758, 21088759, 18061910, 24016081, 24016108, 24108036, 24108044, 24067370, 24067371 and 24077468. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634
- Why
- 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.
- Distributed
- US Nationwide distribution.
- Company
- Instrumentation Laboratory
- Announced
- Recall began