Z-0778-2007

GEM Premier 4000 Laboratory Analyzer

Name: Z-0778-2007 GEM Premier 4000 Laboratory Analyzer
Creator: Instrumentation Laboratory Co.
Published: 2007-03-27
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2007-03-27 / Terminated

FDA source

Instrumentation Laboratory Co. began a recall of GEM Premier 4000 Laboratory Analyzer on 2007-03-27. The reason FDA records is "Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0778-2007
Status: Terminated
Initiated: 2007-03-27
Posted: 2007-05-03
Terminated: 2012-05-23
Recalling firm: Instrumentation Laboratory Co.
Product: GEM Premier 4000 Laboratory Analyzer
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result
FDA root cause: Other
Action: Instrumentation Labs on 3/2707 notified Service Reps to perform on site mandatory upgrade. The foreign counterparts were advised by email on 3/21/07
Quantity in commerce: 210
Distribution: Worldwide, including USA, Australia, Austria, Greece, Spain, Netherlands, Great Britain, France, Germany, Italy, and Sweden
Product codes and lots: Serial numbers prior to 07020343 with Software versions prior to V1.1.3

Product code CHL

K061974Class IIGem Premier 4000 with Iqm, Model 4000; Gem Cvp 1 and 2 with Co-Ox; Gem Cvp 3 and 4 HematocritInstrumentation Laboratory CO / cleared 2006-09-15

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)