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Terminated

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

FDA Recall Z-2761-2019 · Posted 2019-09-27

Recalling FirmHelena Laboratories, Corp.
Recall StatusTerminated
Product CodeGFO
Date Initiated2017-12-07
Date Terminated2020-06-09
Product Quantity21 kits

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.

Firm Action

The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot.

Root Cause

Unknown/Undetermined by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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