Aniara Diagnostica recalls BIOPHEN Protein C 5 kits due to Cesium Chloride in Reagent 2 being classified as hazardous under CLP regulations, suspected of damaging fertility. Affected kits have UDI-DI: 366353700063BD Lot FA083327 and all future lots.
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
Aniara Diagnostica is recalling BIOPHEN Protein C 5 kits because Reagent 2 contains Cesium Chloride, which has been reclassified as hazardous under EU regulations and is suspected of damaging fertility. This affects kits with specific UDI-DI and lot numbers.
Reagent 2 in the BIOPHEN Protein C 5 kit contains Cesium Chloride, which has been reclassified as hazardous under EU regulations. The substance is suspected of damaging fertility, though it does not pose an immediate risk of injury during normal use.
Users of the BIOPHEN Protein C 5 kit for medical testing are affected, particularly those who have the specific UDI-DI and lot numbers listed. Pregnant individuals or those concerned about fertility may be at higher risk.
Check for the UDI-DI: 366353700063BD and Lot FA083327 on the kit. All future lots of this product are also affected.
Look for the UDI-DI: 366353700063BD and Lot FA083327 on the kit label.
The product is safe for use as long as you check the UDI-DI and lot numbers. The hazard is related to fertility, not immediate injury risks.
Check the UDI-DI and lot numbers. If you have the affected numbers, you should stop using the kit and contact Aniara Diagnostica for further instructions.
The product does not pose a risk of injury during normal use. The hazard is related to potential fertility issues, not physical harm.
We’ve drafted a message you can send Aniara Diagnostica to request your refund or repair — edit it as you like.
Subject: Recall Z-1227-2023 — Aniara Diagnostica Aniara Diagnostica Hello, I own a Aniara Diagnostica that is covered by recall Z-1227-2023 from Aniara Diagnostica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
