ELx800 microtiter plate reader software program written for use with ORTHO HCV Version 3.0 ELISA Test System.
FDA device recall Z-1576-05 · posted 2005-10-01 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- An error in the acceptance specification for the substrate blank optical density was discovered in the Bio-Tek ELx800 programming specifications for the ORTHO HCV Version 3.0 ELISA Test System Assay.
- Action taken
- Dear Customer letters, dated 03/08/2004 were sent to customers informing them of the specification error and instructing users to validate their assays manually.
- Root cause
- Other
- Status
- Terminated
- Product code
- MZO
- Quantity affected
- 128
- Distribution
- AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WI & WV
- Date initiated
- 2004-03-09
- Date posted
- 2005-10-01
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.