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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmOctober 29, 2004
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on January 18, 2005
Recall NumberZ-0263-05
Recall Event ID 30394
510(K)NumberK033234 
Product Classification System, Test, Human Chorionic Gonadotropin - Product Code DHA
ProductImmulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
Code Information Serial Number: B0071; B0095; B0055; B0060; B0124; B0131; B0097; B0106; B0064; B0087; B0073; B0113; B0121; B0135; B0122; B0123; B0102.
FEI Number 1000122204
Recalling Firm/
Manufacturer		 DPC Cirrus
62 Flanders Bartley Rd
Flanders NJ 07836-4715
For Additional Information ContactChristopher W. Clegg
973-927-2828 Ext. 4336
Manufacturer Reason
for Recall		Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.
FDA Determined
Cause 2		Other
ActionThe firm faxed the technical bulletin notification to each domestic customer on 10/22/2004. International customers were e-mailed and faxed on the same day.
Quantity in Commerce17 UNITS
DistributionThe firm distributed the IMMULITE 2500 nationwide and internationally. The international customers are located in Portugal, Turkey, Australia, Switzerland, Czech Rep.,Germany, Spain, France, Netherlands, Sweden, Denmark, United Kingdom, and Italy.
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.
510(K) Database510(K)s with Product Code = DHA
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