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U.S. Department of Health and Human Services

Class 2 Device Recall Hemoglobin Test Kits

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  Class 2 Device Recall Hemoglobin Test Kits see related information
Date Initiated by Firm June 29, 2004
Date Posted July 23, 2004
Recall Status1 Terminated 3 on October 29, 2008
Recall Number Z-1158-04
Recall Event ID 29485
510(K)Number K840011  
Product Classification System, Analysis, Electrophoretic Hemoglobin - Product Code JBD
Product RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
Code Information Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
Recalling Firm/
Manufacturer		 PerkinElmer LAS Inc
3985 Eastern Rd
Norton OH 44203-6215
For Additional Information Contact
800-321-9632
Manufacturer Reason
for Recall		 Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.
FDA Determined
Cause 2		 Other
Action The firm contacted their customers via telephone and notified them of the recall on 6/29/2004. A follow-up recall letter was also issued on 6/29/2004. The letter requests that the customer either destroy the product or return it to the firm for replacement. Also attached for completion and to be faxed back to the recalling firm, is a questionaire which documents the customer''s receipt of the product and recall letter; any reports of illness or injury in connection with the use of the product; and the customer''s proposed disposition of the kits i.e. return or destruction. Additional follow-up with all non-responding customers will take place in 2 weeks.
Quantity in Commerce 146
Distribution The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JBD and Original Applicant = ISOLAB, INC.
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