FDA recall Z-1108-2021

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.

Reason for recall

Intermittent potential for shorter than expected clot times.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-01-05

Report date

2021-02-17

Termination date

2024-11-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1108-2021