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

Lot, batch or date codesGEM Premier 5000: Part number: 00024019255 UDI: 08426950870227 Units distributed in United Kingdom: GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. Affected Accessory: Bar Code Reader (BCR) Wand that received a configuration update on or after 8 April 2026. Part No. 00024015859; UDI No. 08426950869634

Quantity recalled67

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-2824-2026
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.

Nationwide

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-2824-2026.

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 United Kingdom: GEM Premier 5000 Serial Nos.: 25110547, 25100462, 25110522, 25100472, 25101897, 25101920, 25101931, 25122029, 26012032, 25122030, 26012033, 26012043, 25110523, 25110536, 25120550, 25069638, 23101109, 24011137, 25081799, 25081797, 25091839, 25091840, 25091864, 25091870, 25091868, 25091873, 25091880, 25091876, 25101886, 25101889, 25101887, 25101891, 25101907, 25101904, 25101912, 25101905, 25101917, 25101921, 25101926, 25101929, 25101934, 25101927, 25111968, 25121986, 25121985, 25121981, 25121984, 25121994, 25121995, 25121982, 25121993, 25121991, 25121999, 25121996, 16030255, 17060782, 17060784, 17060785, 17060789, 17060790, 17060797, 17111126, 17121258, 18011414, 20054515, 20054516 and 22082271. 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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12 Aug 2026Device	CLASS II	The GEM Premier 7000 with iQM3 is a portable critical care recalled	Instrumentation Laboratory	Device Malfunction	Nationwide
12 Aug 2026Device	CLASS II	GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory	Instrumentation Laboratory	Device Malfunction	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
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