Lower riskMedical device recall · FDA · Published March 19, 2019
BIOPHEN UFH Control C1 Recall: Incorrect Instructions for Use in Specific Lots
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.
“BIOPHEN UFH Control C1 Recall: Incorrect Instructions for Use in Specific Lots.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/68602-biophen-ufh-control-c1-recall-incorrect-instructions-for-use-in. Based on FDA recall #Z-1189-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1189-2019%22&limit=1).
Aniara Diagnostica LLC recalled BIOPHEN UFH Control C1, REF 224101, distributed to accounts in Michigan and Pennsylvania, according to the FDA on March 19, 2019. The company packaged incorrect Instructions for Use into specific lots of the device product codes.
The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Aniara Diagnostica LLC has five other recalls on record since July 19, 2019. Other recent recalls of similar products include Broselow Filled Organizer Recall (Dec. 15, 2025), Bioporto ProNephro AKI Reagent Kit Recall (May 18, 2026), and Beckman Coulter Emit 2000 Quinidine Assay Recall (July 13, 2026).
How to tell if you have this one
Check the lot numbers on the device packaging: F1700314P2, F1700314P3, F1700314P4, or F1801638P1. The product is a BIOPHEN UFH Control C1 device.
Brand
Aniara Diagnostica
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
Distributed to accounts in MI and PA.
Recall number
Product, codes & lots
Quantity
Z-1188-2019
BIOPHEN UFH Control C2, REF 223901; Lot F1700315P7
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.
Official source: FDA Recall #Z-1189-2019 (March 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1189-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.