Recall Z-1102-2008 ยท LEH Radioimmunoassay, Vancomycin
Seradyn, Inc.
Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.
| Date | Apr 29, 2008 (initiated Dec 20, 2007) |
| Status | Terminated |
| Reason | False negative test results due to Interfering substances (heterophile antibodies) in the patient's blood may produce erroneously low results. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050419 | QMS VANCOMYCIN Seradyn, Inc., Apr 1, 2005 |