Aniara Diagnostica recalls BIOPHEN UFH Control C1 devices with specific lot numbers due to incorrect Instructions for Use packaging. Affected units may have improper instructions that could lead to improper use.
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
Aniara Diagnostica is recalling specific lots of BIOPHEN UFH Control C1 devices because they were packaged with incorrect Instructions for Use. This could lead to improper use of the device if the instructions are not followed correctly.
The device was packaged with incorrect Instructions for Use in specific lots, which could lead to improper use if healthcare providers follow the wrong instructions. This might result in incorrect dosing or treatment decisions.
Healthcare professionals using the BIOPHEN UFH Control C1 device for blood clot management are most likely affected. Patients using this device under medical supervision may also be impacted if instructions are incorrect.
Check the lot numbers on the device packaging: F1700314P2, F1700314P3, F1700314P4, or F1801638P1. The product is a BIOPHEN UFH Control C1 device.
Verify the lot number on the device packaging to see if it matches the affected lots: F1700314P2, F1700314P3, F1700314P4, or F1801638P1.
The affected lots are F1700314P2, F1700314P3, F1700314P4, and F1801638P1.
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
No, but you should check the lot number to ensure you have an affected unit. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-1189-2019 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-1189-2019 from Aniara Diagnostica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
