ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Laboratories, I
FDA device recall Z-0790-2007 · posted 2007-05-09 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
- Action taken
- Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- n/a
- Distribution
- Folate Reagent distributed to the following countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic
- Date initiated
- 2007-03-28
- Date posted
- 2007-05-09
- Date terminated
- 2007-09-25
- Location
- Irving, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT TESTOSTERONE (K983212) | Abbott Laboratories | 1998-11-18 |