FDA Device Intelligence
Home › INSTRUMENTATION LABORATORY COMPANY › GEM Premier 5000 PAK BG ISE COOX TBILI (150 TEST)

GEM Premier 5000 PAK BG ISE COOX TBILI (150 TEST)

INSTRUMENTATION LABORATORY COMPANY · Model 00055415009XC · UDI-DI 08426951027330

CHL Prescription
1
510(k) clearances
2,392
Adverse events (46 deaths)
184
Recalls
34
Facilities

Description

GEM 5000 BG ISE COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)

Recalls

DateFirmReason
2026-05-21Instrumentation LaboratoryThe active ingredient concentration in the lysing bag solution of specific GEM Premier 7000 with iQM3 PAK lots did not meet established manufacturing specifications. The malfunctio
2026-05-21Instrumentation LaboratoryThe active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing specifications. The malfunction could result
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The
2026-05-08Instrumentation LaboratoryBCR wands that received a configuration update (released under Service Information No. 2026-07 on or after April 8, 2026) may assign patient results to an incorrect patient ID. The
2026-04-02Siemens Healthcare Diagnostics IncUse of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary
2026-04-01Abbott Point Of Care Inc.Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.