Seradyn QMS Vancomycin reagents, Part Number: 0373589.… recallZ-1102-2008 · Seradyn, Inc. · initiated Dec 20, 2007
Terminated All recalls posted in April 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Seradyn, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1102-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 20, 2007
- Posted by the FDA
- Apr 29, 2008
- Recalling firm
- Seradyn, Inc.
- Quantity
- 1,819 kits plus bulk material for 1,863 kits.
- Product code
- LEH
- FDA submissions
- K050419
- 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 description
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
Code information (models, lots, serial numbers)
All lots (lots 501930, 502063, 502074, 600432, 601166, 601207, 602556, 603076, 603801, 603312, 700657 and 703027).
Other devices under the same FDA submission
1 device cleared under K050419 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARCHITECT 6E44-21Abbott Laboratories · RADIOIMMUNOASSAY, VANCOMYCIN5 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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