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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1108-2021
Event ID87151
Event DescriptionCascade 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 TypeDevices
DistributionWorldwide distribution - U.S. Nationwide distribution and the countries of Germany, Italy, Romania, Australia, Chile.
Quantity205 total kits
Recall ReasonIntermittent potential for shorter than expected clot times.
Device Classification20210217
Device Code InfoModel 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 Date20210211
Recall Initiation Date20210105
Recalling FirmHelena Laboratories, Corp.
Initial Notification Letter
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