Helena Laboratories, Corp. recalls Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the

Recalled February 17, 2021 · FDA recall Z-1108-2021 · Helena Laboratories

Hazard

Intermittent potential for shorter than expected clot times. · FDA Class II

Units

205 total kits

Sold at

Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.

Description

Intermittent potential for shorter than expected clot times.

Product

Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.

Manufacturer(s)

Helena Laboratories, Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →