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U.S. Department of Health and Human Services

Class 2 Device Recall Seradyn QMS Vancomycin

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 Class 2 Device Recall Seradyn QMS Vancomycinsee related information
Date Initiated by FirmDecember 20, 2007
Date PostedApril 29, 2008
Recall Status1 Terminated 3 on December 30, 2008
Recall NumberZ-1102-2008
Recall Event ID 46150
510(K)NumberK050419 
Product Classification Vancomycin Radioimmunoassay - Product Code LEH
ProductSeradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
Code Information All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).
Recalling Firm/
Manufacturer		 Seradyn, Inc.
7998 Georgetown Rd
Indianapolis IN 46268-5631
For Additional Information Contact
800-428-4072
Manufacturer Reason
for Recall		False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
FDA Determined
Cause 2		Device Design
ActionConsignees were notified of the problem via Urgent Medical Device Correction letter dated 12/20/07. The letter provided information on the issues concerning the recall. The firm will revise the package insert to address the potential occurrence of false negative bias. If inconsistencies with Vancomycin level exist, confirm with an alternative test method. For further information please contact 1-800-428-4072.
Quantity in Commerce1,819 kits plus bulk material for 1,863 kits.
DistributionWorldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.
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 = LEH
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