Recall Z-1854-2011 ยท GKR System, Hemoglobin, Automated
ITC-Nexus Dx, Inc.
HGBPROKIT which contains one meter and one container of 25 test strips. HGB TEST 100; HGB PRO TEST STRIPS -100, includes four containers of 25 test strips per container; International Technidyne Corporation The Hgb Pro Professional Hemoglobin Testing System Consists of a portable battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary
| Date | Mar 31, 2011 (initiated Jan 21, 2011) |
| Status | Terminated |
| Reason | ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference hemoglobin testing system. |
| Root cause | Other |
| Action | ITC-Nexus Dx, Inc. sent an Urgent Medical Device Recall letter with return response forms to end users and distributors dated January 21, 2011 via UPS overnight. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory to determine if they had an of the affected lots. If they have full boxes or loose containers of the affected lots customers were instructed to stop using the product and remove it from inventory. Customers were requested to fill out the return response form and send it back to ITC via fax, |
| Quantity | 2500 containers + 50,563 addtnl containers =53063 containers |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of India, Oman, South Africa, and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.