Z-1227-2023Class II

BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated...

Name: Z-1227-2023 BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human citrated...
Creator: Aniara Diagnostica LLC
Published: 2023-02-01
License: https://open.fda.gov/license/

Aniara Diagnostica LLC / initiated 2023-02-01 / Open, Classified / root cause: labeling and UDI

FDA source

Aniara Diagnostica LLC began a recall of 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... on 2023-02-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1227-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-01
Posted: 2023-03-06
Recalling firm: Aniara Diagnostica LLC
Product: 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.
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
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
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Aniara issued Medical Field Correction Letter (FSCA#29) prepared by HYPHEN BioMed and emailed to the customer by Aniara Diagnostica on 2/1/23. Letter states reason for recall, health risk and action to take: New labelling will be implemented on all new lots as follow: x A new pictogram added on reagent and box label: GHS08 x Signal Word: Warning x Hazard Statements: H361f - Suspected of damaging fertility x Precautionary Statements: o P201 : Obtain special instructions before use. o P280 : Wear protective gloves/protective clothing/eye protection/face protection. o P308 + P313 : IF exposed or concerned: Get medical advice/attention. o P405 : Store locked up. o P501 : Dispose of contents/container in consultation with your regional waste disposer x Hazardous ingredients : Cesium chloride The IFU, label and SDS will be updated. Please return completed and signed Form to your distributor.
Quantity in commerce: 2 units
Distribution: US Nationwide distribution in the state of NC.
Product codes and lots: UDI-DI: 366353700063BD Lot FA083327 (And all future lots)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1227-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1227-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-06

Product code GGP

K050365Class IIBiophen Protein C5, C2.5, Models 221205, 221202Hyphen Biomed / cleared 2005-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)