Class I Recall of GEM Premier 4000 PAK Cartridges

Kate Johnson

Disclosures

August 02, 2011

August 2, 2011 — Inaccurate potassium readings have been reported from certain GEM Premier 4000 PAK cartridges manufactured by Instrumentation Laboratory Company of Bedford, Massachusetts, according to an alert sent yesterday from MedWatch, the US Food and Drug Administration’s (FDA's) safety information and adverse event reporting program.

The potassium readings are "too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/L by as much as 2.0 mmol/L," the FDA noted. "Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death."

The cartridges, used with the GEM Premier 4000 portable critical care system, were the subject of an FDA class I recall initiated in May 2011.

Class I recalls are "the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the FDA.

The GEM Premier 4000 PAK cartridges are used by healthcare professionals to rapidly analyze a variety of analytes in whole-blood samples, either at the bedside or in a central laboratory.

In a letter to customers, the company previously described how to disable the potassium testing component of the following model and part numbers, manufactured between May 2006 and July 2011:

Description Part Number
GEM 4000 BG/Hct/Lytes/CO-Ox - iQM 00027407508, 00027415008, 00027430008, 00027445008, 00027360008
GEM 4000 BG/Hct/Lytes/G/L/CO-Ox - iQM 00027407510, 00027415010, 00027430010, 00027445010, 00027360010
GEM 4000 BG/Hct/Lytes/CO-Ox/tBili - iQM 00027407509, 00027415009, 00027430009, 00027445009, 00027360009
GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili - iQM 00027407511, 00027415011, 00027430011, 00027445011, 00027360011

The company also has provided customers with a Mandatory Response Tracking Form to be completed and returned immediately by fax at 1-781-861-4207, or by email to ra-usa@ilwww.com.

Customers may also contact the company at 1-800-678-0710 and press 2 at the prompt.

More information about the recall is available on the FDA Web site.

Adverse events related to these products can also be communicated to MedWatch by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, Maryland 20852-9787.

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