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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/
Manufacturer		 PerkinElmer LIfe Sciences Inc
3985 Eastern Rd
Norton OH 44203
For Additional Information Contact
330-825-4525
Manufacturer Reason
for Recall		 The CSF Gels were manufactured incorrectly resulting in irregular wavy bands.
FDA Determined
Cause 2		 Other
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.
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