Z-2165-2011

Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care...

Name: Z-2165-2011 Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care...
Creator: Instrumentation Laboratory Co.
Published: 2011-02-14
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2011-02-14 / Terminated / root cause: design

FDA source

Instrumentation Laboratory Co. began a recall of Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to... on 2011-02-14. The reason FDA records is "Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2165-2011
Status: Terminated
Initiated: 2011-02-14
Posted: 2011-05-10
Terminated: 2012-05-23
Recalling firm: Instrumentation Laboratory Co.
Product: Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-OXimetry (tHb, 02Hb, COHb, MetHb, HHb) parameters. Total bilirubin can also be quantitated from heparinized plasma samples when analyzed in the tBili/CO-Ox mode. These parameters, along with derived parameters, aid in the diagnosis of a patient's acidlbase status, electrolyte and metabolite balance and oxygen delivery capacity. Total bilirubin measurements are used in the diagnosis and management of biliary tract obstructions, liver disease and various hemolytic diseases and disorders involving the metabolism of bilirubin. In neonates, the level of total bilirubin is used to aid in assessing the risk of kernicterus
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results
Root cause tag: design
FDA root cause: Device Design
Action: Instrumentation Laboratory notified accounts by a Field Safety NotifIcation Letter dated Feb 2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use whichever of the following mitigation options works best for their institution. Both options will have the same effect to eliminate the potential impact of a rare spike on the glucose and lactate sensors. Customers were instructed to complete the enclosed Response Tracking Form and return immediately fax to 781-861-4207 or e-mail to [email protected]. Customers were advised to contact their local representative with any questions.
Quantity in commerce: 4379 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of CANADA ISRAEL ITALY APAN KUWAIT MALAYSIA MEXICO NETHERLANDS NORWAY PANAMA POLAND PORTUGAL PUERTO RICO SAUDI ARABIA SLOVENIA SPAIN SWEDEN SWITZERLAND TAIWAN TURKEY UNITED ARAB EMIRATES UNITED KINGDOM and URUGUAY.
Product codes and lots: Serial Numbers range: 06050100 -11024479

Product code CGA

K093623Class IIGem Premier 4000 with Iqm (Addition of Total Bilirubin Parameter), Gem Cvp 2 (Addition of Total Bilirubim Assignment toInstrumentation Laboratory CO / cleared 2010-06-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)