MalfunctionGIT
DADE ACTIN FS ACTIVATED PTT REAGENT
Received Oct 14, 2005
Report 9610806-2005-00025 · MDR key 695909
Device
Generic name
Activated Partial Thromboplastin Time
Manufacturer
Dade Behring GmbhModel number
NACatalog number
B4218-100
Lot number
527263
Product problems
- High Test Results
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
A CUSTOMER OBTAINED ERRONEOUSLY HIGH CONTROLS WITH ACTIN FS LOT 527263. ERRONEOUSLY PROLONGED APTT TEST RESULTS HAVE BEEN OBSERVED WITH ABNORMAL CITROL CONTROLS AND PATIENT SAMPLES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT; TREATMENT WAS NOT PERSCRIBED OR ALTERED BASED ON THE ERRONEOUSLY HIGH CONTROLS. (NOTE: CUSTOMER UNABLE TO PROVIDE DATE OF EVENT).
Remedial action
- Recall