Lower riskMedical device recall · FDA · Published February 1, 2023
BIOPHEN Protein C 5 Kit Recall: Cesium Chloride May Damage Fertility
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
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Contact the company
📍Recalling firmAniara Diagnostica LLC7768 Service Center Dr · West Chester, OH 45069-2442
✎ GovInfoNow plain-language explainer
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. Read more at govinfonow.com/recall/58982-biophen-protein-c-5-kit-recall-cesium-chloride-may-damage.
“BIOPHEN Protein C 5 Kit Recall: Cesium Chloride May Damage Fertility.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58982-biophen-protein-c-5-kit-recall-cesium-chloride-may-damage. Based on FDA recall #Z-1227-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1227-2023%22&limit=1).
The FDA announced on Feb. 1, 2023, that Aniara Diagnostica LLC is recalling its BIOPHEN Protein C 5 kit due to labeling hazards regarding cesium chloride in Reagent 2. The agency issued recall number Z-1227-2023 for the Class II device distributed nationwide in North Carolina.
How to tell if you have it
Brand: Aniara Diagnostica
Product: BIOPHEN Protein C 5 kit
Lot codes: FA083327 and all future lots
UDI-DI: 366353700063BD
Distribution: US Nationwide, including North Carolina
The hazard
The recall addresses new warnings about Reagent 2 containing cesium chloride, which has become hazardous under CLP regulation because it is suspected of damaging fertility. The FDA classified this as a Class II recall for the in vitro diagnostic device.
Context
GovInfoNow's records show Aniara Diagnostica LLC has five other recalls on record since March 19, 2019. Other recent recalls include the 2026-07-01 Aniara Diagnostica 5-PLASMA Bivalirudin Calibrator Recall for stability issues and the 2026-04-01 ZYMUTEST HIA IgG Kit Recall for incorrect positive control values. Similar recent recalls of medical products include the 2026-07-10 Medline C-Section Kits Recall for contaminated components and the 2026-06-12 Medline Convenience Kits Recall for potential sterility breaches.
How to tell if you have this one
Check for the UDI-DI: 366353700063BD and Lot FA083327 on the kit. All future lots of this product are also affected.
Brand
Aniara Diagnostica
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Look for the UDI-DI: 366353700063BD and Lot FA083327 on the kit label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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.
Is there a risk of injury from this product?
The product does not pose a risk of injury during normal use. The hazard is related to potential fertility issues, not physical harm.
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.
Official source: FDA Recall #Z-1227-2023 (February 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1227-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.