ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Laboratories, Irving, TX.
This recall has been terminated (originally issued May 9, 2007).
- Company
- Abbott Laboratories, Inc
- Recall Initiated
- March 28, 2007
- Posted
- May 9, 2007
- Terminated
- September 25, 2007
- Recall Number
- Z-0790-2007
- Firm Location
- Irving, TX
- Official Source
- View on FDA website ↗
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.
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, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, UAE, United Kingdom. No US distribution.
Lot / Code Info
All serial numbers.
Root Cause
Other
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.