Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
- Company
- Diasorin Inc.
- Recall Initiated
- April 12, 2004
- Posted
- April 6, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0673-05
- Quantity
- 8
- Firm Location
- Stillwater, MN
Reason for Recall
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
Distribution
CA, CT, KS, MA & WA
Lot / Code Info
Software version 12
Root Cause
Other
Action Taken
A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
More recalls by Diasorin Inc.
DiaSorin LIAISON Q.S.E.T. Device Plus, REF 319060; intended for use in the preparation of human stoo...
Dec 12, 2024
DiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620
Jan 25, 2024
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended...
Nov 23, 2020
Parvovirus B19 IgG EIA kit
Part No. V519IGUS
Jul 17, 2020