CLASS II ONGOING Device recall · Reported 15 Mar 2023 · FDA Enforcement Report
Biophen Protein C 5 kit recalled by Aniara Diagnostica
Aniara Diagnostica is recalling Biophen Protein C 5 kit is for in vitro quantitative determination of Protein C activity, distributed nationwide in the US. The recall was initiated on 1 Feb 2023 and the FDA has classified it as Class II.
Check your package
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-1227-2023
- FDA event ID
- 91618
- Recalling firm
- Aniara Diagnostica, West Chester, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Feb 2023
- FDA classified
- 6 Mar 2023
- Reported
- 15 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Feb 2023 | Recall initiated by company | |
| 6 Mar 2023 | Classified by FDA | +33 days |
| 15 Mar 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
Product as listed by the FDA
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated plasma. Protein C is a glycoprotein, vitamin K dependent, which inhibits coagulation. Protein C in plasma is measured following a specific activation with Protac (Agkistrodom Contortrix), an enzyme extracted from snake venom. Activated protein C hydrolysis the chromogenic substrate (SaPC-21) which release para-nitroaniline (pNA). The amount of pNA released (measured by absorbance at 405 nm) is directly proportional to the concentration of Protein C in the specimen.
Where it was distributed
US Nationwide distribution in the state of NC.
Questions about this recall
Why was it recalled?
New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification and has become hazardous according to the CLP regulation ((EC) No 1272/2008) is suspected of damaging fertility
Which lots are affected?
UDI-DI: 366353700063BD Lot FA083327 (And all future lots)
Where was it sold?
US Nationwide distribution in the state of NC.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
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