Abbott Laboratories, Inc
23 جمادى الاخرة 1428 هـ الموافق 8 يوليو 2007 م
| Recalling Firm / Manufacturer |
Abbott Laboratories, Inc |
| Product |
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX. |
| Code Information |
All serial numbers. |
| 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. |