Food, drugs, devices › Helena Laboratories, Inc.
Device recall: 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)
Helena Laboratories, Inc. (Beaumont, TX) initiated this device recall on 20 Apr 2016; FDA lists 1 product record under event 81356, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 15 Feb 2024. Initiation: voluntary: firm initiated. Helena Laboratories, Inc. has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Helena Laboratories, Inc., Beaumont, TX.
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"
Distribution
"US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0594-2019 | 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… | 12 Kits | Class II | Terminated | 19 Dec 2018 |
Context
Other enforcement events for Helena Laboratories, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 4 Apr 2017 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citr | Device | Class II | 1 |
| 24 Feb 2017 | 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) | Device | Class II | 1 |
| 7 Nov 2016 | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR | Device | Class III | 1 |
| 14 Oct 2016 | Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL | Device | Class II | 1 |
All 5 events for Helena Laboratories, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 15 Feb 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.