ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
This recall has been terminated (originally issued July 24, 2007).
- Recall Initiated
- May 14, 2007
- Posted
- July 24, 2007
- Terminated
- June 10, 2011
- Recall Number
- Z-1098-2007
- Quantity
- 393
- Firm Location
- Barceloneta, PR
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Puerto Rico
Lot / Code Info
LIST # 01L82-10 Lots # 48253Q101 Exp Date 09/26/2007, 48253Q100Exp Date 06/19/2007, 45556Q100 Exp Date 03/14/2007, 45557Q100 Exp Date 01/01/2007, 44595Q100 Exp Date 02/28/2007, and 42586Q100 Exp Date 01/01/2007
Root 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.