ARCHITECT i System Assay CD-ROM, in vitro diagnostic… recallZ-0413-2007 · Abbott Laboratories MPG · initiated Jan 2, 2007
Terminated All recalls posted in March 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Abbott Laboratories MPG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The ARCHITECT AUSAB and ARCHITECT Anti-HCV assay parameter default interpretation screens when using ARCHITECT Assay CD-ROM US Version 06E58-21 does not align with the result interpretation options in the ARCHITECT AUSAB Reagent Package Insert (PI) 34-4162/R1 and ARCHITECT Anti-HCV PI 34-4152/R1.
FDA root cause category: Other
What the company is doing
On 1/2/07, Abbott sent Product Correction, Immediate Action Required letters dated 12/29/06 to all ARCHITECT AUSAB (list number 1L82-25) and ARCHITECT Anti-HCV customers (list number 1L79-25) who have the affected assay CD-ROM. The end users were informed that for the ARCHITECT AUSAB and ARCHITECT Anti-HCV assays, the default interpretations in the Assay Parameters window, installed from ARCHITECT I System Assay CD-ROM US Version 06E58-21, are not align with the result interpretation options in the package inserts. The accounts were advised to reconfigure the names of the interpretations in Assay Parameters window, following the steps in the enclosed attachments A and B. The accounts were requested to keep a copy of the letter on file until the revised Assay CD-ROM is received. The accounts were requested to complete the customer reply form, indicating that the letter was received, understood and disseminated to the laboratory manager/supervisor responsible for Architect AUSAB and/or Anti-HCV testing, and fax it to Abbott by 1/12/07.
Recall details
- Recall number
- Z-0413-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 2, 2007
- Posted by the FDA
- Mar 8, 2007
- Recalling firm
- Abbott Laboratories MPG
- Quantity
- 51 affected analyzers
- Product code
- JJI
- FDA submissions
- P050051, P050042
- Distribution
- Nationwide
Product description
ARCHITECT i System Assay CD-ROM, in vitro diagnostic analyzer, U.S. Version 21.0; for use on the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list number 06E58-21
Code information (models, lots, serial numbers)
list number 06E58-21, version 21.0, lot 45572P100
Other devices under the same FDA submission
3 devices cleared under P050051, P050042 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARCHITECT 1L79-25Abbott GmbH · ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS1 recall7 reports
- ARCHITECT 1L79-35Abbott GmbH · ASSAY,ENZYME LINKED IMMUNOSORBENT,HEPATITIS C VIRUS1 recall3 reports
- Alinity 08P0521Abbott GmbH · Assay, enzyme linked immunosorbent, hepatitis c virus1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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