DeviceSignal · Recall classified
Instrumentation Laboratory
FDA classified a device recall on 2026-07-29 · Class II · Z-2824-2026
EventRecall classified
Effective2026-07-29
ClassificationClass II
On 2026-07-29 the FDA classified a device recall from Instrumentation Laboratory as Class II. Product: Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number…. Recall Z-2824-2026. The firm initiated it on 2026-05-08. This reports the classification FDA published on that date.
Reported facts
- Recall number
- Z-2824-2026
- Classification
- Class II
- Classified on
- 2026-07-29
- Initiated on
- 2026-05-08
- Firm
- Instrumentation Laboratory
- Reason
- 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
- Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 portable blood analyzer system
Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.
Provenance
- Source
- fda_device_enforcement
- Source record
Z-2824-2026- Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72- Source URL
- https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
- Observed
- 2026-09-08T16:22:09.483Z
- Transform
fda_device_enforcement_to_recall v1- Event rule
fda_device_recall_classified v1- Event key
08cea248e3f55e15b6a657a45acef3c562ee5fd522503f34344a5bb018abd4fc- Signal type
device_recall.classified
Source terms that apply
- This is not a public alerting service and must not be used to notify patients or the public
- We do not report whether a recall is still open; FDA does not maintain that after classification
- Nothing here is a medical or clinical decision aid
- Not affiliated with, endorsed by, or certified by the FDA
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)