ARCHITECT i1000SR" Processing Module System For In Vitro Diagnostic Use, Abbott Laboratories Abbott Park, IL Product Lis
FDA device recall Z-2482-2010 · posted 2010-09-23 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories, Inc
- Reason for recall
- During manufacturing, two components of the ARCHITECT i1000SR were reversed which could potentially cause falsely elevated patient results due to a sample-reagent and reagent-sample carryover.
- Action taken
- ABBOTT issued Technical Service Bulletins to Field Service Representatives who then inspected every unit .
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 404 units distributed worldwide (including US)
- Distribution
- Worldwide distribution:USA including states of: CO, DC, FL, GA, IL, LA, MA, MN, NY, OH, OK, TX, UT, and WV and countries including: Australia, Brazil, Bogota, Canada, China WFOTC, Columbia, Curacao (N
- Date initiated
- 2008-10-21
- Date posted
- 2010-09-23
- Date terminated
- 2012-04-13
- Location
- Irving, TX
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