GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System Recalled because Potassium Test Results are too low

Laboratory and Critical Care Medicine personnel are informed by the FDA that GEM Premier 4000 PAK Cartridges for use on the GEM Premier 4000 System are recalled due to inaccurate results that may cause serious health consequences, including death.

Background of GEM Premier 4000 PAK Cartridges

GEM Premier 4000 PAK Cartridges, by Instrumentation Laboratory Company, are used on the GEM Premier 4000 portable critical care System in order to rapidly analyze whole blood samples.

FDA Alert on GEM Premier 4000 PAK Cartridges

FDA’s reason for the recall is that potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer. This may lead to inappropriate treatment of the patient and serious health consequences.

The affected GEM Premier 4000 PAK Cartridges and lots are:

• GEM 4000 BG/Hct/Lytes/CO-Ox – iQM. Part no: 00027407508, 00027415008, 00027430008, 00027445008, 00027360008
• GEM 4000 BG/Hct/Lytes/G/L/CO-Ox – iQM. Part no: 00027407510, 00027415010, 00027430010, 00027445010, 00027360010
• GEM 4000 BG/Hct/Lytes/CO-Ox/tBili – iQM. Part no: 00027407509, 00027415009, 00027430009, 00027445009, 00027360009
• GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili – iQM. Part no: 00027407511, 00027415011, 00027430011, 00027445011, 00027360011.

The manufacture and distribution dates were from May, 2006 to July 2011.

The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.

Recommendation on GEM Premier 4000 PAK Cartridges

“Customers were directed to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting. See the Class I recall notice for more information, including affected model/part numbers.”

Contacting the FDA to report cases with GEM Premier 4000 PAK Cartridges

In case of detection of adverse events or side effects related to the use of GEM Premier 4000 PAK Cartridges, healthcare professionals and patients should report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting program through any of the following ways:

The report can be completed and submitted online at: www.fda.gov/MedWatch/report.htm

The form can be downloaded or requested by calling 1-800-332-1088, then completed and returned on the address indicated on the form

The completed form can be faxed to: 1-800-FDA-0178

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