CLASS III Device recall · Reported 24 Apr 2019 · FDA Enforcement Report

Biophen UFH Control C2 recalled by Aniara Diagnostica

Aniara Diagnostica is recalling Biophen UFH Control C2, distributed in Michigan, Pennsylvania. The recall was initiated on 19 Mar 2019 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot F1700315P7
Quantity recalled14 kits

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-1188-2019
FDA event ID
82468
Recalling firm
Aniara Diagnostica, West Chester, OH
Classification
Class III
Status
Terminated
Recall initiated
19 Mar 2019
FDA classified
17 Apr 2019
Reported
24 Apr 2019
Type
Voluntary: Firm initiated
Customers notified by
E-Mail
Reason category
Packaging Defects

Timeline

19 Mar 2019Recall initiated by company
17 Apr 2019Classified by FDA+29 days
24 Apr 2019Published in enforcement report+7 days

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

Reason for recall

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

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 C2, REF 223901

Where it was distributed

Distributed to accounts in MI and PA.

MichiganPennsylvania

Questions about this recall

Is Biophen UFH Control C2 recalled?

Yes. Aniara Diagnostica recalled Biophen UFH Control C2 on 19 Mar 2019. The recall is Class III and its status is Terminated. Recall number Z-1188-2019.

Why was it recalled?

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

Which lots are affected?

Lot F1700315P7

Where was it sold?

Distributed to accounts in MI and PA.

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

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