Recall Z-0633-05 ยท LAZ N-Acetylprocainamide Control Materials
Diasorin Inc.
ETI-MP IgM Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative detection of specific IgM antibodies to Mycoplasma pneumoniae in human serum. Test kit for 192 determinations. Catalog No. 4700. For In Vitro Diagnostic use. manufactured for DiaSorin Inc., 1950 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285
| Date | Mar 18, 2005 (initiated Oct 20, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Distribution | MA, OH & IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.