Helena Laboratories, Corp. Recall 87151
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.
Helena Laboratories, Corp. Recall 87151 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1108-2021 |
| Event ID | 87151 |
| Event 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. |
| Product Type | Devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile. |
| Quantity | 205 total kits |
| Recall Reason | Intermittent potential for shorter than expected clot times. |
| Device Classification | 20210217 |
| Device Code Info | 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 |
| Center Classification Date | 20210211 |
| Recall Initiation Date | 20210105 |
| Recalling Firm | Helena Laboratories, Corp. |
| Initial Notification | Letter |
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