Recall Z-2803-2011 ยท CEM Electrode, Ion Specific, Potassium
Instrumentation Laboratory Co.
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Number: 00027407508 150 test iQM Part Number: 00027415008 300 test iQM Part Number : 00027430008 450 test iQM Part Number: 00027445008 600 test iQM Part Number: 00027360008 The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood
| Date | Jul 21, 2011 (initiated May 31, 2011) |
| Status | Terminated |
| Reason | K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Instrumentation Labs, issued a Revised "Urgent Field Safety Notification" letter dated July 14, 2011, to GEM Premier 4000 customers. The letter describes the product, problem, updated issue description and actions to be taken. The customers were instructed to follow the instructions to Disable K+ Parameter ,provided in the letter, to eliminate the potential of erroneous K+ result reporting and to complete and return the MANDATORY RESPONSE TRACKING FORM immediately via fax at 781-861-4207 or email to ra-usa@ilwww.com. The letter also noted an Important Change to Customer Actions |
| Quantity | 2369 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MEXICO, NETHERLANDS, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061974 | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT Instrumentation Laboratory CO, Sep 15, 2006 |
| K093623 | GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO Instrumentation Laboratory CO, Jun 18, 2010 |