CLASS II Device recall · Reported 19 Dec 2018 · FDA Enforcement Report
Cascade Abrazo c-Act-lr Test Card Ivd For IN Vitro recalled
Helena Laboratories is recalling Cascade Abrazo c-Act-lr Test Card Ivd For IN Vitro Diagnostic Use Store at 2 to 8 C, distributed nationwide in the US. The recall was initiated on 20 Apr 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0594-2019
- FDA event ID
- 81356
- Recalling firm
- Helena Laboratories, Beaumont, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2016
- FDA classified
- 10 Dec 2018
- Reported
- 19 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 20 Apr 2016 | Recall initiated by company | |
| 10 Dec 2018 | Classified by FDA | +964 days |
| 19 Dec 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
Questions about this recall
Why was it recalled?
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Which lots are affected?
Lot Codes: 1-15-5701 Model/Catalog Number: 5701
Where was it sold?
US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Helena Laboratories
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Serrated Blade Applicator Kit (12 Sample) recalled | Helena Laboratories | Packaging Defects | 8 states |
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| Device | CLASS II | Cascade Abrazo aPTT Test Card recalled by Helena Laboratories | Helena Laboratories | Other | Nationwide |
| Device | CLASS II | K-act Actalyke Clotting Test Tubes that are used recalled | Helena Laboratories | Device Malfunction | Nationwide |
| Device | CLASS III | Collagen Reagent recalled by Helena Laboratories | Helena Laboratories | Particulate Matter | 10 states |
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