Recall Z-1097-2007
Abbott Diagnostic International, Ltd. · initiated May 14, 2007
Product
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.
Codes / lots: LIST # 01L82-01 Lots # 50337Q100 Exp Date 08/21/2007, 48265Q100 Exp Date 06/13/2007, 45555Q100 Exp Date 03/14/2007, 44594Q100 Exp date 02/28/2007, and 42585Q100 Exp Date 01/01/2007
Reason for recall
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.
FDA-determined cause: Other
Action taken
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 of these results Disregard the automated interpretation of results for low-level reactive samples. A customer reply form will accompany the Product Correction letter. Effectiveness Check Depth: 100% of customers receiving the Product Correction letter. The start date of communication was May 14,2007.
Details
- Recall number
- Z-1097-2007
- Initiated
- May 14, 2007
- Posted by FDA
- July 24, 2007
- Terminated
- June 10, 2011
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Quantity
- 247
- Distribution
- Nationwide and Puerto Rico
- Recalling firm
- Abbott Diagnostic International, Ltd., Barceloneta, PR
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1096-2007 | ARCHITECT AUSAB Reagent list number 1L82-25 has the following components: 1) Architect…During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to… | 05/14/2007Terminated |
| Z-1098-2007 | ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following…During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to… | 05/14/2007Terminated |