Abbott Laboratories, Inc
23 جمادى الاخرة 1428 هـ الموافق 8 يوليو 2007 م
| Recalling Firm / Manufacturer |
Abbott Laboratories, Inc |
| Product |
ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)and 07K60-30 (4 x 500 test kits); manufactured by Abbott Ireland Diagnostic Division, Lisnamuck, Longford, Ireland. |
| Code Information |
Product Control/Lot # (For List #07K60-20): 42908JN00, 42964JN00 and 42905JN00; (For List #07K60-25): 42909JN00, 42965JN00 and 42906JN00; (For List #07K60-30): 42910JN00, 42966JN00, 42907JN00, and 42931JN00. |
| Reason of Recall |
If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results. |
| Date Recall Initiated |
March 28, 2007 |
| Action |
Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level. Firm Initiated recall is ongoing. |
| Contact |
Abbott Diagnostics Division
Saudi Arabia
(02) 6511077 |
| Source of Information |
U.S. FDA |
| SFDA Comments |
SFDA urges all hospitals that have devices subjected to recall, to contact the company. |