Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
FDA Recall Z-1102-2008 · Posted 2008-04-29
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Recalling FirmSeradyn, Inc.
Recall StatusTerminated
Product CodeLEH
Date Initiated2007-12-20
Date Terminated2008-12-30
Product Quantity1,819 kits plus bulk material for 1,863 kits.
Reason for Recall
False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
Firm Action
Consignees 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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