Recall Z-2806-2011
Instrumentation Laboratory Co. · initiated May 31, 2011
Product
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test iQM Part Number:00027407511 150 test iQM Part Number: 00027415011 300 test iQM Part Number: 00027430011 450 test iQM Part Number: 00027445011 600 test iQM part Number: 00027360011 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.
Codes / lots: All in date cartridges
Reason for recall
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
FDA-determined cause: Nonconforming Material/Component
Action taken
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 from June Urgent Field Safety Notification. Prior strategy : Instrumentation Laboratories (IL) notified U.S and Canadian customers via the Urgent Field Safety Notification mailed USPS between June 2 - 3,2011. International Affiliates / Dealers notified through e-mail on June 1, 2010. A response (tracking) form was included. A Worldwide Regulatory Notice was e-mailed on May 31.2011.to IL country affiliates and distributors, notifying them of the issue, providing a risk summary and the support documentation for the notification. The customer notification will be handled per their local regulatory requirements. If you have questions regarding this notification, please contact IL at 800-678-0710, press 2 at prompt.
Details
- Recall number
- Z-2806-2011
- Initiated
- May 31, 2011
- Posted by FDA
- July 21, 2011
- Terminated
- November 27, 2012
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Quantity
- 1442
- 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, NORWAY, PANAMA, POLAND, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND…
- Recalling firm
- Instrumentation Laboratory Co., Bedford, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2803-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |
| Z-2804-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |
| Z-2805-2011 | GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM…K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding… | 05/31/2011Terminated |