CLASS II ONGOING Device recall · Reported 18 Mar 2026 · FDA Enforcement Report

GEM Premier 5000 PAK recalled by Instrumentation Laboratory

Instrumentation Laboratory is recalling GEM Premier 5000 PAK, distributed nationwide in the US. The recall was initiated on 20 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X.

Quantity recalled51 units

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-1524-2026
FDA event ID: 98349
Recalling firm: Instrumentation Laboratory, Bedford, MA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jan 2026
FDA classified: 10 Mar 2026
Reported: 18 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

20 Jan 2026	Recall initiated by company
10 Mar 2026	Classified by FDA	+49 days
18 Mar 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors during warm-up, including consecutive occurrences, resulting in GEM PAK ejection and requiring insertion of a new GEM PAK. iQM2 is an active quality process control program designed to provide continuous monitoring of the entire testing process. Thus, if a GEM PAK completes AutoPAK Validation following warm-up, it may remain in use. Consecutive GEM PAK ejections during warm-up may prolong turnaround times, potentially delaying results. In such cases, patient management may require reassessment once results are available. While many GEM PAKs continue to perform as intended, consecutive ejections may increase the likelihood of operational disruption, highlighting the importance of advance planning where feasible to help minimize impact.

Product as listed by the FDA

GEM Premier 5000 PAK, Part No. 00055360004.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Bulgaria, Brazil, Belarus, Switzerland, Canada, Chile, China, Colombia, Czech Republic, Germany, Denmark, Dominican Republic, Ecuador, Estonia, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, South Korea, Kazakhstan, Lebanon, Lithuania, Luxembourg, Latvia, Macau, Mexico, Malaysia, Netherlands, New Zealand, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, San Marino, South Africa, Thailand, Tunisia, Turkey, Uruguay, Uzbekistan & Vietnam.

Nationwide Georgia

Questions about this recall

Is GEM Premier 5000 PAK recalled?

Yes. Instrumentation Laboratory recalled GEM Premier 5000 PAK on 20 Jan 2026. The recall is Class II and its status is Ongoing. Recall number Z-1524-2026.

Why was it recalled?

Which lots are affected?

Part number: 00055360004; UDI: 08426950899662; Lot No. 251113U, 251201AI, 251202Q, 251223E, 251223P, 251229X.

Where was it sold?

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.

More recalls from Instrumentation Laboratory

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Reported	Class	Recall	Company	Reason	Where
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
5 Aug 2026Device	CLASS II	GEM Premier 5000 with IQM2 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide
5 Aug 2026Device	CLASS II	GEM Premier 7000 with iQM3 recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide

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