Instrumentation Laboratory

Certain GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer may fail quality control checks during startup, causing the cartridge to eject and need replacement. This can delay test results and require you to insert a new cartridge. The issue affects specific lot numbers distributed worldwide.

Instrumentation Laboratory GEM PAK cartridges (part number 00055445008) for the GEM Premier 5000 blood gas analyzer may eject repeatedly during warm-up due to detection errors. This can delay test results and require operator intervention to restart testing. The issue affects 70 units distributed worldwide.

Some GEM PAK cartridges used in Instrumentation Laboratory's GEM Premier 5000 blood analyzer are experiencing repeated detection errors during startup, causing cartridges to eject unexpectedly. This can delay test results and require operators to insert replacement cartridges. The issue affects 130 units distributed worldwide.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated "Process Control Solution Not Detected" errors during startup, causing the cartridges to be ejected and requiring replacement. This can delay test results. The affected cartridges are lot numbers 251114K, 251205K, and 251215D (Part No. 00055430011).

Certain GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer may eject repeatedly during startup due to detection errors. This can cause delays in test results and require staff to replace cartridges multiple times. The issue affects specific lot numbers manufactured between October and December 2025.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood analyzer are experiencing increased errors during startup that cause the cartridge to eject prematurely. This may require staff to insert a new cartridge and repeat the startup process, which can delay test results. The device's built-in quality monitoring system (iQM2) continues to verify results, so cartridges that pass validation can remain in use.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing repeated error messages during startup that cause the cartridge to eject. This may delay test results and require inserting replacement cartridges. The affected cartridges are from specific lot numbers manufactured in late 2025.

Instrumentation Laboratory has identified that GEM PAK cartridges for the GEM Premier 5000 blood gas analyzer may fail quality checks during startup, causing the cartridge to eject. This can happen multiple times in a row, which delays test results. The cartridges that pass quality checks after startup can continue to be used.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer are experiencing increased errors during warm-up that cause them to eject unexpectedly. This can require repeated cartridge replacements and may delay test results. Most cartridges continue to work normally, but consecutive ejections could disrupt lab operations.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer may reject during the warm-up process, requiring replacement cartridges to be inserted. This can delay test results and may require doctors to reassess patient care once results are available. The issue affects specific lot numbers distributed worldwide.

Some GEM PAK cartridges for the Instrumentation Laboratory GEM Premier 5000 blood gas analyzer are ejecting repeatedly during warm-up due to detection errors. This can delay test results and require staff to insert new cartridges multiple times. The device's quality control system (iQM2) will catch problems, but consecutive ejections may slow lab operations.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject unexpectedly. This can delay test results and require staff to insert a new cartridge. Most cartridges continue to work normally, but consecutive failures may disrupt lab operations.

Instrumentation Laboratory has identified that some GEM PAK cartridges (part no. 00055407511) for the GEM Premier 5000 blood analyzer may fail quality checks more frequently during startup, causing the cartridge to be ejected. This can delay test results and may require multiple cartridge replacements. The GEM Premier 5000's built-in quality monitoring system (iQM2) will catch and reject any cartridges that do not pass validation, so cartridges that complete the validation process remain safe to use.

Some GEM Premier 5000 PAK cartridges (Part No. 00055407510) may fail to detect process control solution during warm-up, causing the cartridge to eject. This can require staff to insert a new cartridge and may delay test results. Most cartridges work normally, but some lots are experiencing repeated ejection problems.

Some GEM PAK cartridges (Part No. 00055407508) for the GEM Premier 5000 blood analyzer may eject repeatedly during warm-up due to detection errors. This can delay test results and require staff to insert new cartridges multiple times. Most cartridges work normally, but some batches show higher error rates.

Certain cartridges (PAKs) for the GEM Premier 5000 blood analyzer may fail to detect process control solution during startup, causing the cartridge to eject and need replacement. This can delay test results. The issue affects 28 specific lot numbers distributed worldwide.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject and need replacement. This can delay test results and may require doctors to reassess patient care once results are available.

Certain cartridges (GEM PAKs) for the Instrumentation Laboratory GEM Premier 5000 blood analyzer may fail to detect a required control solution during startup, causing the cartridge to be ejected. This can happen multiple times in a row, delaying test results. Many cartridges work normally, but affected lots may cause operational delays.

Instrumentation Laboratory GEM Premier 5000 PAK cartridges (part number 00055360008) in certain lots may fail to detect process control solution during warm-up, causing the cartridge to eject unexpectedly. This can delay test results and require staff to insert a new cartridge. The quality control system will catch cartridges that fail validation, and affected cartridges can still be used if they pass validation.

Some GEM PAK cartridges for the GEM Premier 5000 blood analyzer may fail to detect process control solution during warm-up, causing the cartridge to eject and need replacement. This can delay test results. The issue affects 51 cartridges from specific lot numbers distributed worldwide.

Instrumentation Laboratory has recalled a coagulation test reagent (Part Number 0020006800, Lot N1136730) used to evaluate blood clotting and monitor heparin therapy due to potential microbial contamination. The affected lot expires 12/31/2025 and was distributed worldwide including multiple U.S. states and countries. No injuries have been reported to date.

Instrumentation Laboratory recalled specific lots of HemosIL SynthAFax Partial Thromboplastin Time tests because they were manufactured with twice the intended amount of preservative. This could affect test accuracy. No injuries have been reported.