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Terminated

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

FDA Recall Z-2165-2011 · Posted 2011-05-10

Recalling FirmInstrumentation Laboratory Co.
Recall StatusTerminated
Product CodeCGA
Date Initiated2011-02-14
Date Terminated2012-05-23
Product Quantity4379 units

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

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093623GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TOInstrumentation Laboratory CO · 2010-06-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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