GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part Number : 00027407510 150 test
FDA device recall Z-2804-2011 · posted 2011-07-21 · Terminated
Recall details
- Recalling firm
- Instrumentation Laboratory Co.
- 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
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 24787
- Distribution
- Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANC
- Date initiated
- 2011-05-31
- Date posted
- 2011-07-21
- Date terminated
- 2012-11-27
- Location
- Bedford, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO (K093623) | Instrumentation Laboratory CO | 2010-06-18 |