The Recall Desk
SevereFDA (Devices)·Z-2900-2026·Announced 2026-08-12

GEM Premier 5000 PAK Lysing Solution Concentration Recall

Specific lots of the GEM Premier 5000 PAK lysing bag solution have an active ingredient concentration that does not meet manufacturing specifications, which could delay recognition and management of Co-Oximetry and total bilirubin abnormalities.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall of a medical device where the malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae, meeting the rubric criterion for FDA Class II with potential for serious health consequences.

Plain-English summary

The U.S. Food and Drug Administration has classified a recall of specific lots of the GEM Premier 5000 PAK, a medical device product manufactured by Instrumentation Laboratory. The recall affects 109 units distributed nationwide in the United States and internationally in China, Germany, and Italy.

The reason for the recall is that the active ingredient concentration in the lysing bag solution of the affected lots did not meet established manufacturing specifications. This malfunction could result in delayed recognition and management of Co-Oximetry and total bilirubin abnormalities and their sequelae.

The affected lots include Part Numbers 00055360010, 00055360011, 00055407504, 00055415010, 00055430010, 00055430011, 00055445010, 00055445011, and 00055360010.A, with specific lot numbers identified by the FDA.

Consumers and healthcare facilities should contact Instrumentation Laboratory regarding the recalled units. The recall is classified as FDA Class II, indicating a potential risk of temporary or medically reversible adverse health consequences.

The recalled product

Product
GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360010.A
Manufacturer
Instrumentation Laboratory
Category
Medical Device — Blood Gas Analyzer PAK
Hazard
Affected units
109

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 15 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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