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U.S. Department of Health and Human Services

Class 3 Device Recall ETIMP IgM

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 Class 3 Device Recall ETIMP IgMsee related information
Date Initiated by FirmOctober 20, 2004
Date PostedMarch 18, 2005
Recall Status1 Terminated 3 on July 22, 2006
Recall NumberZ-0633-05
Recall Event ID 30930
Product Classification N-Acetylprocainamide Control Materials - Product Code LAZ
ProductETI-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
Code Information lot # E052660D, E052790D
FEI Number 2182595
Recalling Firm/
Manufacturer		 Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
For Additional Information ContactDiaSorin Technical Services
800-328-1482
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionCustomers 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.
DistributionMA, OH & IL
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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