Recall Z-0791-2007 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Abbott Laboratories, Inc
ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX.
| Date | May 9, 2007 (initiated Mar 28, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, Finland, France, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983212 | ABBOTT ARCHITECT TESTOSTERONE Abbott Laboratories, Nov 18, 1998 |