Roche CoaguChek PT market withdrawal
This article was originally published in The Gray Sheet
Executive Summary
Class I recall notice Sept. 26 cites possible corruption caused by misalignment of "easy-open" notches on prothrombin test strip packaging during manufacturing. Users of the test alerted Roche of the problem, and on Sept. 12 the firm asked patients to discard lots 591 and 619. Users are encouraged to "inspect each pouch prior to use...and run two strips each time they test" to ensure accuracy of all other lots. The firm will replace damaged packaging and maintains that the problem is corrected. A similar issue among European lots led to a UK recall Sept. 9...