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.
Reported: February 17, 2021 Initiated: January 5, 2021 #Z-1108-2021
Product Description
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.
Reason for Recall
Intermittent potential for shorter than expected clot times.
Details
- Recalling Firm
- Helena Laboratories, Corp.
- Units Affected
- 205 total kits
- Distribution
- Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
- Location
- Beaumont, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Helena Laboratories, Corp.. Units affected: 205 total kits.
Why was this product recalled? ▼
Intermittent potential for shorter than expected clot times.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1108-2021.
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