Aniara Diagnostica LLC: Medical Device Recall in 2022 - (Recall #: Z-1743-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

BIOPHEN UFH Control Plasma

Product Classification:

Class III

Date Initiated: June 28, 2022
Date Posted: September 21, 2022
Recall Number: Z-1743-2022
Event ID: 90765
Reason for Recall:

Incorrect product labeling was included in the package.

Status: Terminated
Product Quantity: 13 units (1 unit is 1 box)
Code Information:

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

Distribution Pattern:

Distribution in US - IL and MI

Voluntary or Mandated:

Voluntary: Firm initiated