Z-1102-2008

Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN

Name: Z-1102-2008 Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN
Creator: Seradyn, Inc.
Published: 2007-12-20
License: https://open.fda.gov/license/

Seradyn, Inc. / initiated 2007-12-20 / Terminated / root cause: design

FDA source

Seradyn, Inc. began a recall of Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN on 2007-12-20. The reason FDA records is "False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1102-2008
Status: Terminated
Initiated: 2007-12-20
Posted: 2008-04-29
Terminated: 2008-12-30
Recalling firm: Seradyn, Inc.
Product: Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
Product code: LEH Radioimmunoassay, Vancomycin
Reason for recall: False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1,819 kits plus bulk material for 1,863 kits.
Distribution: Worldwide Distribution --- USA including states of California and New York, and countries of Australia, Belgium, Canada, Finland, Germany, Ireland, Japan, Spain and United Kingdom.
Product codes and lots: All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).

Product code LEH

K050419Class IIQms VancomycinSeradyn, Inc. / cleared 2005-04-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)