| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CAPTURE-CMV INDICATOR RED CELLS | ANTI-IGG AND ANTI-IGM COATED RED CELLS INTENDED FOR USE IN CAPTURE-CMV ASSAYS | IMMUCOR, INC. | LJO | 0066238 | 228149 | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2011-06-28 | 0 |
Patient 1
A CUSTOMER REPORTED DONORS SAMPLES THAT WERE PREVIOUSLY REPORTED OUT AS CMV NEGATIVE ARE NOW DISPLAYING POSITIVE REACTIVITY ON THE GALILEO. THE CUSTOMER STATED NO REPEAT TESTING ON THE INSTRUMENT WAS DONE OR WILL BE PERFORMED. THE CUSTOMER STATED NO ADVERSE EVENT OCCURRED AS A RESULT OF THE UNEXPECTED REACTIONS.
Patient 1
PERFORMED A CMV ASSAY ON 24 KNOWN NEGATIVE CMV DONORS ON THE GALILEO USING ONE FULL PLATE OF RETENTION CAPTURE-CMV, LOT (B)(4) AND CAPTURE-CMV INDICATOR RED CELLS, LOT (B)(4). CONTROLS PERFORMED AS EXPECTED AND 22 OF THE DONORS TESTED NEGATIVE AS EXPECTED. TWO OF THE DONORS REPEATEDLY TESTED POSITIVE (X3). THOSE DONORS TESTED CMV NEGATIVE USING CAPTURE-CMV INDICATOR RED CELLS, (B)(4). RETENTION PRODUCTS DID NOT PERFORM AS EXPECTED. PERFORMED A CMV ASSAY ON 6 KNOWN CMV NEGATIVE IN HOUSE DONORS ON THE GALILEO USING RETENTION CAPTURE-CMV, LOT (B)(4) AND THE CUSTOMERS RETURNED VIALS OF CAPTURE-CMV INDICATOR RED CELLS, LOT (B)(4). CONTROLS PERFORMED AS EXPECTED AND ALL IN HOUSE DONORS TESTED NEGATIVE AS EXPECTED WITH THE FIRST VIAL TESTED. ONE OF THE 6 DONORS TESTED POSITIVE WHEN USING THE SECOND VIAL. RETURNED PRODUCTS DID NOT PERFORM AS EXPECTED. PERFORMED A CMV ASSAY ON THE CUSTOMERS RETURNED SAMPLES ON THE GALILEO USING RETENTION CAPTURE-CMV, LOT C087 AND CAPTURE-CMV INDICATOR RED CELLS, LOT (B)(4). CONTROLS PERFORMED AS EXPECTED AND ONLY SAMPLE (B)(6) TESTED NEGATIVE. ALL FOUR SAMPLES TESTED POSITIVE. A SERVICE CALL WAS MADE. ADJUSTMENTS MADE TO THE INSTRUMENT AS NEEDED. TESTED CMV NEGATIVE PATIENT SAMPLES, 7/9 SAMPLES CAME OUT WEAK POSITIVE. INSTRUMENT IS WORKING WITHIN SPECIFICATIONS MECHANICALLY. CANNOT RULE OUT THAT THE CMV INDICATOR CELLS MAY HAVE BEEN COMPROMISED.