CLASS III Device recall · Reported 21 Sep 2022 · FDA Enforcement Report

Biophen UFH Control Plasma recalled by Aniara Diagnostica

Aniara Diagnostica is recalling Biophen UFH Control Plasma, distributed in Illinois, Michigan. The recall was initiated on 28 Jun 2022 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 03663537008290 Reference No.: 223101; Lot Code: FA2035

Quantity recalled13 units (1 unit is 1 box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1743-2022
FDA event ID: 90765
Recalling firm: Aniara Diagnostica, West Chester, OH
Classification: Class III
Status: Terminated
Recall initiated: 28 Jun 2022
FDA classified: 15 Sep 2022
Reported: 21 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

28 Jun 2022	Recall initiated by company
15 Sep 2022	Classified by FDA	+79 days
21 Sep 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect product labeling was included in the package.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

BIOPHEN UFH Control Plasma

Where it was distributed

Distribution in US - IL and MI

Illinois Michigan

Questions about this recall

Why was it recalled?

Incorrect product labeling was included in the package.

Which lots are affected?

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

Where was it sold?

Distribution in US - IL and MI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aniara Diagnostica

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