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Instrumentation Laboratory GEM Premier 4000 recallZ-2165-2011 · Instrumentation Laboratory Co. · initiated Feb 14, 2011

Terminated All recalls posted in May 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Instrumentation Laboratory Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2165-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 14, 2011
Posted by the FDA
May 10, 2011
Recalling firm
Instrumentation Laboratory Co.
Quantity
4379 units
Product code
CGA
FDA submissions
K093623
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 description

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

Code information (models, lots, serial numbers)

Serial Numbers range: 06050100 -11024479

Other devices under the same FDA submission

1 device cleared under K093623 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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