Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic.
Brand
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila
Lot Codes / Batch Numbers
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
Products Sold
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
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila is recalling ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Nega due to 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. . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026