Official recall notice
FDA Recall: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Po
- Recall date
- 2026-08-05
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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
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