Recalls for Test, Hepatitis B (b Antigen, B Surface Antigen, Be Antigen)

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

Potential for positively biased results due to signal reduction over shelf life.

Affected lots may experience increased calibration failures or an increase in falsely elevated results.

Anti-HBe2 (aHBe2) interference with the Hepatitis B e Antigen (HBeAg) Assay, leads to elevated or reactive Hepatitis B e Antigen (HBeAg) results on samples that are non-reactive when HBeAg testing follows aHBe2 testing, regardless of whether both tests are performed on the same sample

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Increased imprecision and positive bias is observed with patient samples and negative controls and can result in an increase in initial reactive results.

Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.

The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data from the EVOLIS analyzer to Laboratory Information Systems (LIS) when using the MONOLISA Anti-HBs EIA Quantitative Determination in EVOLIS APF version 6.0.

Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.

Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR

Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey zone or low positive result.

Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating, resulting in decreased binding and lower absorbance. Internal testing has confirmed that when defined assay validation criteria pass, analytical performance is co

The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:6 dilution and invalidate the assay.

Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.

Incorrect results: Reagents in these lots were manufactured with an incorrect ratio of 2 key components, which could result in both false reactive and false nonreactive specimens.

Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.

During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.

During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.

During an internal study, the Architect AUSAB assay was found to read preparations of the WHO standard up to 53% higher than the WHO assigned value. This has the potential to cause elevated results and may impact the interpretation for a small percentage of results with grayzone or low-level reactive concentrations and higher proficiency sample results.

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument.

Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types.

Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as 'Not Confirmed'.

There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.

Aspiration errors in the conjugate component due to microbial contamination of the conjugate.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.

The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.