--- title: "Aniara Diagnostica LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Aniara Diagnostica LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/aniara-diagnostica-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Aniara Diagnostica LLC recall records **5** reported ongoing 6 records in this archive. Latest source date Jul 1, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jul 1, 2026 FDA device enforcement ### [5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905](https://isitonrecall.com/recall/fda-device-z-2894-2026-5-plasma-bivalirudin-amr-verification-kit-model-number-5d-45905/) Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, NC, TN. [Official source for 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2894-2026%22) Jul 1, 2026 FDA device enforcement ### [5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905](https://isitonrecall.com/recall/fda-device-z-2895-2026-5-plasma-bivalirudin-calibrator-model-number-5d-46905/) Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, NC, TN. [Official source for 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2895-2026%22) Jul 1, 2026 FDA device enforcement ### [5-PLASMA Bivalirudin Control, Model Number 5D-44905](https://isitonrecall.com/recall/fda-device-z-2896-2026-5-plasma-bivalirudin-control-model-number-5d-44905/) Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. Class II Reported ongoing Distribution: US Nationwide distribution in the states of IL, NC, TN. [Official source for 5-PLASMA Bivalirudin Control, Model Number 5D-44905](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2896-2026%22) Apr 1, 2026 FDA device enforcement ### [ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A](https://isitonrecall.com/recall/fda-device-z-2171-2026-zymutest-hia-igg-in-vitro-diagnostic-elisa-kit-ref-rk040a/) Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. Class II Reported ongoing Distribution: US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI [Official source for ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2171-2026%22) Feb 1, 2023 FDA device enforcement ### [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 inhibi...](https://isitonrecall.com/recall/fda-device-z-1227-2023-biophen-protein-c-5-kit-is-for-in-vitro-quantitative-determination-of-protein-c-activity-on-human-ci/) 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)... Class II Reported ongoing Distribution: US Nationwide distribution in the state of NC. [Official source for BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1227-2023%22) Jun 28, 2022 FDA device enforcement ### [BIOPHEN UFH Control Plasma](https://isitonrecall.com/recall/fda-device-z-1743-2022-biophen-ufh-control-plasma/) Incorrect product labeling was included in the package. Class III Reported terminated Distribution: Distribution in US - IL and MI [Official source for BIOPHEN UFH Control Plasma](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1743-2022%22) ## Reasons in these listed records - Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin in the controls, calibrators, and linearity values. - Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control. - 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 dam... - Incorrect product labeling was included in the package. These examples come from this result page and are not a ranking of every recall reason. ## Checking Aniara Diagnostica LLC ### Is there a recall on aniara diagnostica llc right now? This archive contains 6 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Aniara Diagnostica LLC](https://isitonrecall.com/check/?q=Aniara%20Diagnostica%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)