Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
USBrand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Recalling Firm: Instrumentation Laboratory
Reason for Recall / 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 & Identification
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Affected Products
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Additional Source Details
| Field | Value |
|---|---|
| City | Bedford |
| State | MA |
| Event id | 99115 |
| Address 1 | 180 Hartwell Rd |
| Address 2 | N/A |
| Code info | 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 |
| Postal code | 01730-2443 |
| Report date | 20260805 |
| Product type | Devices |
| Product quantity | 27 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260508 |
| Initial firm notification | Letter |
| Center classification date | 20260729 |
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Overview
- Recalling FirmInstrumentation Laboratory
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.
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🚨 SAFETY ALERT: Instrumentation Laboratory - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system Check if your household is affected: https://therecallfile.com/recalls/brand-name-gem-premier-5000-product-name-gem-premier-5000-model-catalo/FDA-Z-2823-2026
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