Health Canada Recalls GEM PAKs for GEM Premier 5000 Due to Errors

Detected March 17th, 2026

Summary

Health Canada has issued a recall for GEM PAKs used with the GEM Premier 5000 due to an increased incidence of 'Process Control Solution Not Detected' errors. These errors can lead to GEM PAK ejection and require replacement, potentially delaying patient management.

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What changed

Health Canada is recalling specific GEM PAKs for the GEM Premier 5000 diagnostic instrument due to a higher-than-expected rate of 'Process Control Solution Not Detected' (PCSND) errors. These errors can cause GEM PAK ejection, necessitating the insertion of a new cartridge. While the iQM2 quality control program may allow some affected GEM PAKs to remain in use if they pass validation, consecutive ejections can disrupt operations and potentially delay patient management.

Healthcare providers using the affected GEM PAKs should contact Werfen Technical Support for additional information. While many GEM PAKs function correctly, the potential for operational disruption means that advance planning may be necessary to minimize iQM2 impacts. The recall highlights the importance of monitoring device performance and having contingency plans for potential delays in patient care.

What to do next

Contact manufacturer for additional information regarding affected lots and serial numbers.
Assess potential impact of PCSND errors on patient management turnaround times.
Develop contingency plans for potential operational disruptions due to GEM PAK ejection.

Source document (simplified)

Health product recall

GEM PAKs for the GEM Premier 5000 with iQM2

Brand(s)

INSTRUMENTATION LABORATORY CO.

Last updated

2026-03-17

Summary

Product GEM PAKs for the GEM Premier 5000 with iQM2 Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

CONTACT WERFEN TECHNICAL SUPPORT AT 1-800-678-0710

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055415004 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055430004 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055445004 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055430011 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055415011 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055360008 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055407508 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055415008 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055445008 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055430008 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055415010 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055430010 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055407510 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055360010 |
| Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2 | More than 10 numbers, contact manufacturer. | 00055445010 |

Issue

The company confirmed customer complaints indicating that specific 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 appropriate patient management. In such cases, patient management may require reassessment once results are available. While many GEM PAK s 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.