Aniara Diagnostica LLC: Medical Device Recall in 2019 - (Recall #: Z-1189-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

BIOPHEN UFH Control C1, REF 224101

Product Classification:

Class III

Date Initiated: March 19, 2019

Date Posted: April 24, 2019

Recall Number: Z-1189-2019

Event ID: 82468

Reason for Recall:

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

Status: Terminated

Product Quantity: 41 units

Code Information:

Lots F1700314P2, F1700314P3, F1700314P4, F1801638P1

Distribution Pattern:

Distributed to accounts in MI and PA.

Voluntary or Mandated:

Voluntary: Firm initiated