CLASS II ONGOING Device recall · Reported 12 Aug 2026 · FDA Enforcement Report

GEM Premier 5000 PAK Part Numbers recalled by Instrumentation Laboratory

Instrumentation Laboratory is recalling GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;

Quantity recalled109 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-2900-2026
FDA event ID: 99128
Recalling firm: Instrumentation Laboratory, Bedford, MA
Classification: Class II
Status: Ongoing
Recall initiated: 21 May 2026
FDA classified: 6 Aug 2026
Reported: 12 Aug 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 May 2026	Recall initiated by company
6 Aug 2026	Classified by FDA	+77 days
12 Aug 2026	Published in enforcement report	+6 days

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

Reason for recall

The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A

Where it was distributed

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.

Nationwide Arizona California Florida Georgia Illinois Indiana Kentucky Minnesota Missouri Montana Ohio Pennsylvania Virginia Wisconsin West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Part No. 00055360010 UDI-DI 08426950807599 Lots 260505K, 260504AG, 260505F; Part No. 00055360011 UDI-DI 08426950807605 Lots 260505F and 260505J; Part No. 00055407504 UDI-DI 08426950807537 Lot 260505R; Part No. 00055415010 UDI-DI 08426950807698 Lots 260505H and 260505K; Part No. 00055430010 UDI-DI 08426950807759 Lots 260505H, 260505K and 260505F; Part No. 00055430011 UDI-DI 08426950807766 Lot 260505K; Product No. 00055445010 UDI-DI 08426950807810 Lots 260504AA and 260505K; Product No. 00055445011 UDI-DI 08426950807827 Lots 260505F and 260505J; Product No. 00055360010.A UDI-DI 08426950807599 Lot 260504AF;

Where was it sold?

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, GA, IL, IN, KY, MN, MO, MT, OH, PA, VA, WI, WV and the countries of China, Germany, Italy.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 99128

Reported	Class	Recall	Company	Reason	Where
12 Aug 2026	CLASS II	The GEM Premier 7000 with iQM3 is a portable critical care recalled	Instrumentation Laboratory	Device Malfunction	Nationwide

More recalls from Instrumentation Laboratory

All 77

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
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
5 Aug 2026Device	CLASS II	GEM Premier recalled by Instrumentation Laboratory	Instrumentation Laboratory	Other	Nationwide

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