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Terminated

BIOPHEN UFH Control Plasma

FDA Recall Z-1743-2022 · Posted None

Recalling FirmAniara Diagnostica LLC
Recall StatusTerminated
Product CodeGGN
Date Initiated2022-06-28
Date Terminated2024-04-18
Product Quantity13 units (1 unit is 1 box)

Reason for Recall

Incorrect product labeling was included in the package.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Distribution in US - IL and MI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051472BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATORHyphen Biomed · 2005-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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