Z-0594-2019Class II

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

Name: Z-0594-2019 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: 2016-04-20
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2016-04-20 / 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 The Cascade Abrazo... on 2016-04-20. FDA classified it as Class II and gives the reason as "Due to some cards in this lot experiencing variations in 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-0594-2019
Classification: Class II
Status: Terminated
Initiated: 2016-04-20
Posted: 2018-12-10
Terminated: 2024-02-15
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 The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
Product code: JPB Hemoglobin M
Reason for recall: Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Root cause tag: design
FDA root cause: Device Design
Action: On 04/20/2016 the firm, Helena Laboratories, contacted affected users via email, and then sent a "WITHDRAWAL NOTIFICATION" (dated April 25, 2016) on 04/27/2016. The notification described the product, problem and actions to be taken. The firm instructed the customers/distributors to disposes of affected lot, as a preventive quality measure. The Withdrawal Notification for Removal of Product from Inventory stated, This lot is to be handled by Distributors, as follows: ___ Prevent any shipments or scheduled demonstrations with this lot ___ Remove this lot from Available Inventory and discard the cards ___ Place cards in Quarantine pending disposal ___ Contact International Sales for credit and delivery of replacement cards Verify amount REMOVED FROM STOCK: Total number pulled: ____________________ Date _____________________________ The following signifies written certification that this lot has not been sent to an end user: Verified by: _____________________________________________________________ Please complete this form and return a copy to Helena Laboratories, via: FAX: 409-842-1874 or e-mail to [email protected] For questions, contact Mgr., Technical Services at: 1 (409) 842-3714 ext. 1177. *Reason for removal: Some cards in this lot are experiencing variations in wave form, resulting in possible shorter, or longer, times than expected. While this issue, if present, should be found via use of the Quality Control materials, due to its intermittent nature in the cards, this alone cannot be relied upon.
Quantity in commerce: 12 Kits
Distribution: US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
Product codes and lots: Lot Codes: 1-15-5701 Model/Catalog Number: 5701

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0594-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0594-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-19	2018-12-10

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)