ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycopla
FDA device recall Z-0633-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- 2 lots of ETI-MP IgM assay kits showed a decline in Optical Density (OD) reading of the positive control and calibrators, P10 and P50. The decline in OD of the positive control and calibrators (P10 & P50) would cause the assay validation criteria to fail.
- Action taken
- Customers were sent notification letters. Recommended to detroy the remaining kits and requested a form be returned which indicates the number of kits destroyed so they can arrange replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- LAZ
- Distribution
- MA, OH & IL
- Date initiated
- 2004-10-20
- Date posted
- 2005-03-18
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
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