MalfunctionJKD
ARCHITECT C-PEPTIDE REAGENT
Received Aug 6, 2011 · Event occurred Jul 6, 2011
Report 1415939-2011-00523 · MDR key 2194244
Device
Product problems
- High Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4): HIGH TEST RESULTS. THE CAUSE OF THE ARCHITECT C-PEPTIDE FALSELY ELEVATED QUALITY CONTROLS AND PATIENT RESULTS WAS DUE TO A NEW ANTIBODY LOT USED IN THE MANUFACTURING OF THE C-PEPTIDE MICROPARTICLE AND/OR CONJUGATE REAGENTS. ABBOTT ISSUED A PRODUCT RECALL LETTER TO ALL CUSTOMERS WITH INSTRUCTIONS TO DISCARD AND DESTROY ANY REMAINING INVENTORY OF THE AFFECTED LOTS.
Description of Event or Problem
THE CUSTOMER OBSERVED BIORAD IMMUNOASSAY PLUS CONTROLS OUT OF RANGE HIGH WHEN ARCHITECT C-PEPTIDE REAGENT LOT 00611E000 WAS IN USE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.
Remedial action
- Recall