Abbott Diagnostic International, Ltd
04 رجب 1428 هـ الموافق 18 يوليو 2007 م
| Recalling Firm / Manufacturer |
Abbott Diagnostic International, Ltd. |
| Product |
IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer. |
| Code Information |
Lot #41610Q100; Expiration date 04/25/2008 |
| Reason of Recall |
A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve). |
| Date Recall Initiated |
April 11, 2007 |
| Action |
On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted. 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. |