CLASS II Device recall · Reported 12 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 24 Feb 2017 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-0561-2019
- FDA event ID
- 81378
- Recalling firm
- Helena Laboratories, Beaumont, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2017
- FDA classified
- 6 Dec 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 24 Feb 2017 | Recall initiated by company | |
| 6 Dec 2018 | Classified by FDA | +650 days |
| 12 Dec 2018 | Published in enforcement report | +6 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 reported to have experienced variations in results, (verified by 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
Where it was distributed
US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
Questions about this recall
Is Cascade Abrazo c-Act-lr Test Card Ivd For IN Vitro Diagnostic Use Store at 2 to 8 C recalled?
Yes. Helena Laboratories recalled Cascade Abrazo c-Act-lr Test Card Ivd For IN Vitro Diagnostic Use Store at 2 to 8 C on 24 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-0561-2019.
Why was it recalled?
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.
Which lots are affected?
Lot Codes: 1-16-5701 Model/Catalog Number: 5701
Where was it sold?
US: Products under control of Manufacturer in TX OUS: Four International Distributors - 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.
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