Z-1108-2021Class II

Cascade Abrazo aPTT Test Card -

Name: Z-1108-2021 Cascade Abrazo aPTT Test Card -
Creator: Helena Laboratories, Corp.
Published: 2021-01-05
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2021-01-05 / Terminated

FDA source

Helena Laboratories, Corp. began a recall of Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial... on 2021-01-05. FDA classified it as Class II and gives the reason as "Intermittent potential for shorter than expected clot times". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1108-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-05
Posted: 2021-02-11
Terminated: 2024-11-19
Recalling firm: Helena Laboratories, Corp.
Product: Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Product code: GFO Activated Partial Thromboplastin
Reason for recall: Intermittent potential for shorter than expected clot times.
FDA root cause: Under Investigation by firm
Action: On 01/05/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via email to it distributors informing them that this Recall has been identified due to the potential for shorter than expected clot times on abnormal patients and on abnormal controls on some cards from specific lots and the use of these products may include difficulty achieving abnormal control results in range and incorrectly low patient results. Distributors were instructed to: 1) Immediately examine their inventory and quarantine the specific product lots 2) If they have further distributed the affected product, they are to identify these customers and notify them at once. In addition, the notification to their customers may be enhanced by including a copy of the recall notification letter, which must include instruction of what customers should do with the recalled product. 3) Complete and return enclosed response form as soon as possible Any questions, email or contact Dr. Jessica Jones Hanka at [email protected] or 1-800-231-5663 ext. 1177. Distributors were contacted by email and requested to evaluate inventory while the Recalling Firm investigated issue . Distributors were formally notified of recall on 1/5/2021 and provided with a template for a notification letter to translate and send to end users in each country. End users will be asked to return unused product to the distributor, and distributors will forward all returned product to Helena Labs. Distributors will be asked to provide an account of all product distributed. Effectiveness will be determined by evaluating the total product returned and the total product accounted for based on information provided by distributors.
Quantity in commerce: 205 total kits
Distribution: Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
Product codes and lots: Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021; 3-20-5722 expiration date 11/30/2021; 4-20-5722 expiration date 12/31/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1108-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1108-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-11

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)