ARCHITECT i2000SR Processing Module, for in vitro diagnostics, List Number 3M74-01; manufactured by Abbot Laboratories, Irving, TX.
FDA Recall Z-0791-2007 · Posted 2007-05-09
Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2007-03-28
Date Terminated2007-09-25
Product Quantityn/a
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.