Ortho-Clinical Diagnostics: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.; Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. VITROS CRBM Slides quantitatively measure carbamazepine (CRBM) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integra

Agency: Food and Drug Administration (FDA)

Event ID: 65572

Status: Resolved

Manufacturer: Ortho-Clinical Diagnostics

Manufactured In: United States

Units Affected: 37 products (16732 units (12208 units domestically & 4524 internationally); 544 units (48 domestically & 496 internationally); 16583 units (3073 domestically & 13510 internationally); 28501 units (20321 domestically & 8180 internationally); 183267 units (89415 units domestically & 93852 units internationally); 24322 units (12329 units domestically & 11993 units internationally); 70,125 units (20,219 units domestically & 49,906 units internationally); 197,552 units (88,537 units domestically & 109,015 units internationally); 74,792 units (35,501 units domestically & 60,291 units internationally); 31,0947 units (139,602 units domestically & 171,345 units internationally); 231,112 units (133,173 units domestically & 97,939 units internationally); 11,135 units (153 units domestically & 10,982 internationally); 28,855 units (12,472 units domestically & 16,383 units internationally); 86,503 units (30,378 units domestically & 56,125 units internationally); 28,739 units (480 units domestically & 32,739 units internationally); 12,484 units (9,040 units domestically & 3,444 units internationally); 364,752 units (148,285 units domestically & 216,467 units internationally); 86,522 units (30,717 units domestically & 55,805 units internationally); 24,857 units (17,887 units domestically & 6970 units internationally); 100.393 units (36,873 units domestically & 63,520 units internationally); 205,534 units (137,887 units domestically & 67,647 units internationally); 37,525 units (11,898 units domestically & 25,627 units internationally); 349,072 units (142,455 units domestically & 205,617 units internationally); 28,633 units (14,634 units domestically & 13,999 units internationally); 62,039 units (5,974 units domestically & 4,702 units internationally); 62,039 units (26,765 units domestically & 35,274 units internationally); 101,976 units (39,909 units domestically & 62,067 units internationally); 6,606 units (5,071 units domestically & 1,535 units internationally); 81,382 units (28,256 units domestically & 53,126 units internationally); 21,163 units (16,218 units domestically & 4,945 units internationally); 19,438 units (8,845 units domestically & 10,593 units internationally); 15,492 units (11,870 units domestically & 3,622 units internationally); 175,689 units (86,745 units domestically & 88,944 units internationally); 7,926 units (6,026 units domestically & 1,900 units internationally); 127,662 units (42,487 units domestically & 84,906 units internationally); 31,395 units (10,864 units domestically & 20,531 units internationally); 85,646 units (13,640 units domestically & 72,006 units internationally))