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U.S. Department of Health and Human Services

Class 2 Device Recall Cerebrospinal Fluid Test Kit

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  Class 2 Device Recall Cerebrospinal Fluid Test Kit see related information
Date Initiated by Firm May 16, 2002
Date Posted July 02, 2003
Recall Status1 Terminated 3 on October 24, 2008
Recall Number Z-0973-03
Recall Event ID 26227
510(K)Number k843122  
Product Resolve Systems Cerebrospinal Fluid Test Kit, 50 tests per kit, Catalog #FR-8050.
Code Information Lot #204016, Exp 09 NOV 02
Recalling Firm/
PerkinElmer LIfe Sciences Inc
3985 Eastern Rd
Norton OH 44203
For Additional Information Contact
Manufacturer Reason
for Recall
The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
FDA Determined
Cause 2
Action The firm contacted the consignee by telephone on 5/16/2002.
Quantity in Commerce 10 kits
Distribution The kits were shipped to one (1) consignee located in California.

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) Database 510(K)s with Product Code = and Original Applicant = ISOLAB, INC.