Recall Z-2165-2011 ยท CGA Glucose Oxidase, Glucose
Instrumentation Laboratory Co.
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, glucos
| Date | May 10, 2011 (initiated Feb 14, 2011) |
| Status | Terminated |
| Reason | Measurement (amperometric) spike can occur early in cartridge life on the glucose and lactate sensors during patient blood analysis, leading to erroneously high results |
| Root cause | Device Design |
| 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 ra-usa@ilww.com. Customers were advi |
| Quantity | 4379 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| 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 |