Z-1098-2007

ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative...

Name: Z-1098-2007 ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative...
Creator: Abbott Diagnostic International, Ltd.
Published: 2007-05-14
License: https://open.fda.gov/license/

Abbott Diagnostic International, Ltd. / initiated 2007-05-14 / Terminated

FDA source

Abbott Diagnostic International, Ltd. began a recall of ARCHITECT AUSAB Controls list number 1L82-10 have two bottles with the following components: 1) Negative Control and 2) Positive Control. in vitro diagnostic on 2007-05-14. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1098-2007
Status: Terminated
Initiated: 2007-05-14
Posted: 2007-07-24
Terminated: 2011-06-10
Recalling firm: Abbott Diagnostic International, Ltd.
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.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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 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 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.
Quantity in commerce: 393
Distribution: Nationwide and Puerto Rico
Product codes and lots: 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

Product code LOM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)