Recall Z-1097-2007 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Abbott Diagnostic International, Ltd.
Architect AUSAB Calibrators IVD - list number 1L82-01 has six (6) bottles with the following companents: 1) Calibrator A and 2) Calibrators B thru F. in vitro diagnostic.
| Date | Jul 24, 2007 (initiated May 14, 2007) |
| Status | Terminated |
| Reason | During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results. |
| Root cause | Other |
| Action | All ARCHITECT AUSAB U.S. customers will be contacted. New customers will be contacted through a Product Information Letter that will be included in all ARCHITECT AUSAB Reagent Kits until assay is restandardized. All ARCHITECT AUSAB U.S. customers will be contacted. The following communication types were used: Product Correction Letter Customer Reply Form > Product Information Letter to be included in new kits to be distributed. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed to: Please follow their laboratory procedures for evaluation |
| Quantity | 247 |
| Distribution | Nationwide and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.