RecallDepth

BIOPHEN UFH Control Plasma

Company
Aniara Diagnostica Llc
Recall Initiated
June 28, 2022
Terminated
April 18, 2024
Recall Number
Z-1743-2022
Quantity
13 units (1 unit is 1 box)
Firm Location
West Chester, OH

Reason for Recall

Incorrect product labeling was included in the package.

Distribution

Distribution in US - IL and MI

Lot / Code Info

UDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035

Root Cause

Under Investigation by firm

Action Taken

A recall notification letter was issued on August 3, 2022 to impacted consignees. Consignees were informed that the product is packaged with the incorrect insert ("flyer"). The recalling firm instructs consignees to destroy the included incorrect insert and use the attached correct insert. An Awareness Acknowledgement Form should be completed and returned to the recalling firm acknowledging that the information was received and the incorrect inserts were destroyed.

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