Instrumentation Laboratory Recalls

21 recalls found for Instrumentation Laboratory. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 GEM PAK Recall Affects 74 Units Worldwide

A worldwide distribution recall covers 74 GEM PAK cartridges for the GEM Premier 5000. The issue involves PCSND errors during warm-up that can trigger ejection of GEM PAKs and may delay results. Institutions should follow recall instructions from Instrumentation Laboratory and notify healthcare teams immediately.

Instrumentation Laboratory
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall 1,607 Units Worldwide (2026)

Instrumentation Laboratory recalled 1,607 GEM Premier 5000 units worldwide after complaints of PCSND errors during warm-up that eject GEM PAK cartridges. iQM2 monitors the process and may allow continued use after AutoPAK Validation. Stop using the device and follow IL recall instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls 7 GEM Premier 5000 Units Over PCSND Errors (2026)

Instrumentation Laboratory recalled seven GEM Premier 5000 units worldwide, including the US. PCSND errors during warm-up may cause GEM PAK cartridges to eject, potentially delaying results. Healthcare providers using these devices should stop using the affected units and contact IL for instructions and a remedy.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall for PCSND Errors in 195 Units (2026)

Instrumentation Laboratory’s GEM Premier 5000 was recalled for 195 units distributed worldwide to hospitals and clinical labs. The recall follows complaints of increased Process Control Solution Not Detected errors during warm-up, which can eject GEM PAK cartridges. Hospitals should stop using the device immediately and contact IL for instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalled 180 GEM Premier 5000 PAK Cartridges for PCSND Errors (2026)

Instrumentation Laboratory recalls 180 GEM Premier 5000 PAK cartridges distributed worldwide after reports of PCSND errors during warm-up. During warm-up, GEM PAKs may eject and require insertion of a new GEM PAK. Hospitals should stop using the affected cartridges and follow the manufacturer's recall instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall of 130 GEM PAK Cartridges for PCSND Errors (2026)

Instrumentation Laboratory recalled 130 GEM PAK cartridges for the GEM Premier 5000 after confirmed complaints of Process Control Solution Not Detected errors during warm-up. The issue can cause GEM PAKs to eject and delay test turnaround. Healthcare facilities should stop using the affected cartridges and follow manufacturer instructions for recall guidance.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 Recall 25 Units in 2026

Instrumentation Laboratory is recalling 25 GEM PAK cartridges for the GEM Premier 5000 after complaints of PCSND errors during warm-up. The issues can cause consecutive GEM PAK ejections. The recall affects units distributed worldwide to healthcare facilities. Stop using the affected cartridges and follow manufacturer instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 PAK Recall Worldwide in 2026 for PCSND Warm-Up Errors

Instrumentation Laboratory recalled 1,225 GEM Premier 5000 PAK cartridges worldwide on 2026-01-20 after concerns of PCSND errors during warm-up. The errors can trigger GEM PAK cartridge ejection and may require insertion of a new PAK, delaying results. Stop using the device immediately and follow the manufacturer’s recall instructions.

Instrumentation Laboratory
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 PAK Recall 2026 for 51 Units

Instrumentation Laboratory recalled 51 GEM Premier 5000 PAK cartridges worldwide after complaints of PCSND errors during warm-up. These errors can cause GEM PAK cartridges to eject. The recall could delay results and affect patient management. Stop using the affected cartridges and follow recall instructions from Instrumentation Laboratory.

Instrumentation Laboratory
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 GEM PAK Recalled for 1,629 Units Worldwide (2026)

Instrumentation Laboratory recalled 1,629 GEM Premier 5000 cartridges worldwide on Jan. 20, 2026 after customers reported increased PCSND errors during warm-up. Consecutive ejections may prolong turnaround times and delay results. Stop using affected GEM PAKs and follow recall instructions from the manufacturer.

Instrumentation Laboratory
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory GEM Premier 5000 PAK Recalled for PCSND Warm-Up Errors (30 Units, 2026)

Instrumentation Laboratory is recalling 30 GEM Premier 5000 PAK cartridges distributed worldwide, including the United States. The affected cartridges may experience PCSND errors during warm-up, causing GEM PAKs to eject. Stop using the product and follow recall instructions from the manufacturer for refunds or replacements.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls GEM Premier 5000 GEM PAK Cartridges Over PCSND Errors, 1,989 US/3

GEM Premier 5000 recall announced for 1,989 units distributed worldwide, including the US and numerous other countries. The issue involves GEM PAK cartridges experiencing Process Control Solution Not Detected errors during warm-up, causing ejections and potential delays in patient results. Stop using the device and follow manufacturer recall instructions.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalling 10 GEM Premier 5000 PAK Cartridges for PCSND Error During Warm‑

Instrumentation Laboratory recalled 10 GEM Premier 5000 PAK cartridges sold worldwide after reports of increased PCSND errors during warm‑up. The issue can cause GEM PAK ejections and delays in results. Clinicians and labs should follow the manufacturer’s recall instructions and seek guidance from their healthcare provider.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalling 1,126 GEM PAK Cartridges for GEM Premier 5000 Over PCSND Errors

Instrumentation Laboratory issued a high-severity recall for 1,126 GEM PAK cartridges used with the GEM Premier 5000. The recall cites increased PCSND errors during warm-up that can cause consecutive GEM PAK ejections. The issue may delay patient results. Hospitals should halt use and follow manufacturer instructions immediately.

Instrumentation Laboratory
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls 352 GEM PAK Cartridges for GEM Premier 5000 Over PCSND Errors

Instrumentation Laboratory recalls 352 GEM PAK cartridges for the GEM Premier 5000 worldwide due to increased PCSND errors during warm-up, risking delayed results. Medical facilities should stop using affected GEM PAKs and follow recall instructions. Manufacturers will provide further guidance to healthcare providers and patients.

Instrumentation Laboratory
Confirmed customer
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Health & Personal Care
HIGH
FDA DEVICE

Instrumentation Laboratory Recalls 489 GEM Premier 5000 PAK Cartridges Over PCSND Errors in Warm-Up

Instrumentation Laboratory recalls 489 GEM Premier 5000 PAK cartridges worldwide after reports of Process Control Solution Not Detected errors during warm-up. iQM2 monitors the testing process and may allow continued use after AutoPAK Validation. The recall highlights potential operational disruptions in patient management.

Instrumentation Laboratory
Confirmed customer
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