CanadaGEM PAK cartridges for the GEM Premier 5000 with iQM2 (catalogue numbers include, for example, 00055415004, 00055430004, 00055445004, 00055430011, 00055415011, 00055360008, 00055407508, 00055415008, 00055445008, 00055430008, 00055415010) are affected. The company reported an increased incidence of “Process Control Solution Not Detected” (PCSND) errors during warm-up that can eject GEM PAKs, sometimes consecutively, potentially prolonging turnaround times and delaying patient management. Contact Werfen Technical Support at 1-800-678-0710 for additional information.
What's being recalled
Companies: Instrumentation Laboratory Co., 180 Hartwell Road, Bedford, Massachusetts, United States, 01730-2443.
How to identify it
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055415004
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055430004
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055445004
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055430011
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Tbili, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055415011
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055360008
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055407508
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055415008
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055445008
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055430008
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055415010
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055430010
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055407510
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055360010
Affected products: Gem Premier 5000 Pak Ph, Pco2, Po2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, Thb, O2hb, Cohb, Methb, Hhb, So2; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 00055445010
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
CONTACT WERFEN TECHNICAL SUPPORT AT 1-800-678-0710
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)