Seradyn, Inc. Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
Brand
Seradyn, Inc.
Lot Codes / Batch Numbers
All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).
Products Sold
All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).
Seradyn, Inc. is recalling Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN. due to False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NY
Page updated: Jan 10, 2026