Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
FDA device recall Z-1102-2008 · posted 2008-04-29 · Terminated
Recall details
- Recalling firm
- Seradyn, Inc.
- Reason for recall
- False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results.
- Action taken
- 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
- Status
- Terminated
- Product code
- LEH
- Quantity affected
- 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.
- Date initiated
- 2007-12-20
- Date posted
- 2008-04-29
- Date terminated
- 2008-12-30
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| QMS VANCOMYCIN (K050419) | Seradyn, Inc. | 2005-04-01 |