Recall Z-0958-2007 ยท LER Fluorescent Immunoassay, Theophylline
Abbott Diagnostic International, Ltd.
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.
| Date | Jul 3, 2007 (initiated Apr 11, 2007) |
| Status | Terminated |
| Reason | 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). |
| Root cause | Other |
| Action | An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and pro |
| Quantity | 17 Kits |
| Distribution | Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K833070 | TDX THEOPHYLLINE Abbott Laboratories, Nov 14, 1983 |