Z-2761-2019Class II

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

Name: Z-2761-2019 Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena...
Creator: Helena Laboratories, Corp.
Published: 2017-12-07
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2017-12-07 / Terminated

FDA source

Helena Laboratories, Corp. began a recall of Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX on 2017-12-07. FDA classified it as Class II and gives the reason as "Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2761-2019
Classification: Class II
Status: Terminated
Initiated: 2017-12-07
Posted: 2019-09-27
Terminated: 2020-06-09
Recalling firm: Helena Laboratories, Corp.
Product: Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Product code: GFO Activated Partial Thromboplastin
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.
FDA root cause: Unknown/Undetermined by 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.
Quantity in commerce: 21 kits
Distribution: Distribution was made to Germany and Australia. There was no U.S. distribution.
Product codes and lots: Lot number 2-17-5722, Exp. 2018-09-30

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2761-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2761-2019	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-09-30

Product code GFO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)