CLASS II ONGOING Device recall · Reported 5 Aug 2026 · FDA Enforcement Report
GEM Premier recalled by Instrumentation Laboratory
Instrumentation Laboratory is recalling GEM Premier 5000, distributed nationwide in the US. The recall was initiated on 8 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2825-2026
- FDA event ID
- 99115
- Recalling firm
- Instrumentation Laboratory, Bedford, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 May 2026
- FDA classified
- 29 Jul 2026
- Reported
- 5 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 8 May 2026 | Recall initiated by company | |
| 29 Jul 2026 | Classified by FDA | +82 days |
| 5 Aug 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is GEM Premier 5000 recalled?
Yes. Instrumentation Laboratory recalled GEM Premier 5000 on 8 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2825-2026.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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