Z-0561-2019Class II

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES...

Name: Z-0561-2019 Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES...
Creator: Helena Laboratories, Inc.
Published: 2017-02-24
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2017-02-24 / Terminated / root cause: design

FDA source

Helena Laboratories, Inc. began a recall of Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY on 2017-02-24. FDA classified it as Class II and gives the reason as "Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0561-2019
Classification: Class II
Status: Terminated
Initiated: 2017-02-24
Posted: 2018-12-06
Terminated: 2023-10-20
Recalling firm: Helena Laboratories, Corp.
Product: Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY
Product code: JPB Hemoglobin M
Reason for recall: Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Root cause tag: design
FDA root cause: Device Design
Action: On 02/24/2017, the firm sent an email to affected users, with a Withdrawal Notification. The firm informed the customers/distributors that Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. On 04/12/2017, the firm mailed formal letters to all customers. PUBLIC CONTACT: "Name: Dr. Jessica Jones Hanka "Title: Technical Services Manager "Address: 1530 Lindbergh Drive, Beaumont, TX 77707 "Telephone #: (409) 842-3714 x1177 "Email: [email protected]
Quantity in commerce: 27 kits
Distribution: US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
Product codes and lots: Lot Codes: 1-16-5701 Model/Catalog Number: 5701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0561-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-12	2018-12-06

Product code JPB

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)