FDA recall Z-2761-2019

Product

Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason for recall

Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.

Distribution

Distribution was made to Germany and Australia. There was no U.S. distribution.

Key facts

Status

Terminated

Initiation date

2017-12-07

Report date

2019-10-09

Termination date

2020-06-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2761-2019