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Cms (b)(4) a customer contacted ortho global technical solution center (gtsc) on 07nov2025 after observing what was described as discordant negative reactions in antibody screen and identification in iat for one patient sample using 0.8% surgiscreen lot vss683, 0.8% resolve panel c lot vrc341 and ortho mts anti-igg gel card lot 052025001-01 on their ortho vision id-mts analyzer (b)(6).Complainant/complaint reporter: (b)(6)- medical technologist; (b)(4) date of event: (b)(6) 2025, reported on 07nov2025 reagents: 0.8% resolve panel c lot vrc341, expiration: 28oct2025, manufacture: 12aug2025 mts anti-igg gel card lot 052025001-01, expiration: 09mar2026, manufacture: 09jun2025 other reagents: 0.8% surgiscreen lot vss683, expiration: 28oct2025 0.8% resolve panel b lot vrb342, expiration: 28oct2025 patient information: patient has previous history of anti-jkb antibody.The customer reported that on (b)(6) 2025, a sample from the patient was tested for antibody screening using 0.8% surgiscreen lot vss683 and mts anti-igg gel card lot 052025001-01 on their ortho vision analyzer (b)(6), and that they had obtained a weak positive reaction with cell 3 of the reagent red cell.The customer stated the anti-e(rh3) was not demonstrating.No further details were provided.On the same day, they had tested the same sample for antibody identification using 0.8% resolve panel b lot vrb342 with the same anti-igg card lot on the same analyzer and that they had obtained: - positive reactions (weak positive reaction strength) with cells 15,17,18,20, and 21.The customer stated on the same day they tested the same sample with a competitor's red cell reagent 3% panel, converted to 0.8%, and obtained positive results with cells 3 and 4, which are jkb(jk2) antigen positive and e(rh3) antigen negative.No further details were provided.The customer stated on the same day, the same sample was tested for antibody identification using 0.8% resolve panel c lot vrc341 and mts anti-igg gel card lot 052025001-01 on the same analyzer and that they had obtained weak positive reactions with untreated and ficin-treated cells 5, 9, 10, and 11.Customer reported the anti-e(rh3) was not demonstrating.The customer stated that they sent the patient sample to a reference lab due to non-specific reactions on the panels.The reference lab identified an anti-e(rh3) antibody via ficin-treated panel in gel with other weak positive non-specific reactions.No further details were provided.The customer reported that no biased result was reported to the physician.The customer reported that the patient was not harmed as a result of the reported events.
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The customer stated that quality control (qc) for the panel passed.Confirmation was not provided.The card and reagent red blood cells storage and usage conditions were checked and confirmed to be aligned with ortho's recommendations.The customer reported no visual appearance defects for the gel cards and reagent red blood cells.Gtsc advised the customer when testing using enzyme treated cells, the use of mts buffered gel cards is recommended, as per the ifu.According to ortho lot-specific information for 0.8% surgiscreen lot vss683, cells 1 and 3 are negative for e(rh3) antigen and cell 2 is positive and homozygous for e(rh3) antigen.Cell 3 is positive and homozygous for jkb(jk2) antigen.Therefore, it follows that the negative reaction with cell 2 obtained with the patient sample is not consistent with the expected reactivity of an anti-e(rh3) antibody, and the positive reaction with cell 3 is consistent with the expected reactivity of a weak anti-jkb antibody.According to ortho lot-specific information for 0.8% resolve panel b lot vrb342, cells 15, 16, and 17 are positive and homozygous for e(rh3) antigen, cells 20 and 21 are positive and heterozygous for e(rh3) antigen, and the remaining cells are negative for e(rh3) antigen.Cells 15 and 20 are positive and homozygous for the jkb antigen, and cells 16, 18, 21, and 22 are positive and heterozygous for the jkb antigen.Therefore, it follows that: - the weakly positive reaction obtained with cells 15, 17, 20, and 21 in iat is consistent with the expected reactivity of a weak anti-e(rh3) antibody.- the weakly positive reaction obtained with cells 15, 18, 20, and 21 in iat is consistent with the expected reactivity of a weak anti-jkb(jk2) antibody.- the negative reaction obtained with cell 16 in iat for the patient is not consistent with the expected reactivity of an anti-e(rh3) antibody and is consistent with the expected reactivity of a weak anti-jkb(jk2) antibody.- the negative reaction obtained with cell 22 in iat for the patient is consistent with the expected reactivity of an anti-e(rh3) and weak anti-jkb(jk2) antibody.According to ortho lot specific information for 0.8% resolve panel c lot vrc341, cell 3 is positive and homozygous, cell 6 is positive and heterozygous, and the remaining nine cells are negative for e(rh3) antigen.Cells 1, 3, 9 and 11 are positive and homozygous, cells 4, 5, 7, and 8 are positive and heterozygous, and the remaining three cells are negative for the jkb(jk2) antigen.Therefore, it follows that: - the weakly positive reactions obtained with cells 5, 9, and 11 in iat is consistent with the expected reactivity of a weak anti-jkb(jk2) antibody.- the weakly positive reaction obtained with cell 10 is consistent with non-specific reactions reported by the customer.- the negative reactions obtained with untreated and ficin-treated cells 3 and 6 in iat are not consistent with the expected reactivity of an anti-e(rh3) antibody.A review of manufacturing batch record of the 0.8% resolve panel c lot vrc341 was carried out at ortho's manufacturing site and no non-conformances or deviations were identified.The results of all in-process and quality assurance release testing were found to be within specification, including antigen specificity test.A review of the batch record of the mts anti-igg gel card lot 052025001-01 was also performed at ortho's manufacturing site.The device history record for this lot was reviewed, and no discrepancies were discovered.All in-process and final release serological testing results were within specifications, including customer use ortho vision testing results.All qc inspection records (packaging and gel card inspection documents) of this product lot indicated acceptable results; no gel card defects were identified during qc inspection.All id-mts gel cards used during in-process qc testing passed the visual check performed by the serologist.Formulation stage batch record (anti-igg lot 05205001) associated with this id-mts gel card lot was reviewed and no discrepancies were discovered.The equipment area use log used during production of this lot was reviewed and no conditions or actions taken were found to directly contribute to this customer complaint.There were no product nonconformances related to this lot.The lot met all specifications, all in-process and product release criteria.Retain testing of the 0.8% resolve panel c lot vrc341 was not performed as part of the investigation, as the complaint was reported post product expiration.Testing of retained mts anti-igg card lot 052025001-01 was requested from ortho's manufacturing site.Retention cards were tested on the vision analyzer with 0.8% resolve panel c (ficin treated and untreated) lot vrc342 (vrc341 was expired at the time of testing) and ortho daily qc lot eb026 containing anti-d, anti-c and anti-fya.Samples containing anti-e were not available.A total of 100 retention cards were visually inspected, and no defects were found.Product testing with retain cards performed as expected.No discrepant results were obtained with ortho daily qc samples.Mts anti-igg card lot 052025001-01 performed as intended.A review of the complaints associated with the red cell reagents manufactured using the same donors as those used to manufacture e(rh3) antigen positive cells of 0.8% resolve panel c lot vrc341 was performed.No systematic failure or trend with these donors was identified.The review of the worldwide complaint databases was performed for 0.8% resolve panel c lot vrc341 and mts anti-igg gel card lot 052025001-01, including master bulk lot 052025001 through 20nov2025.One additional complaint was identified for false negative results reported against vrc341 for a different antibody.No complaints for false negative results were identified for the gel card lot 052025001-01.Only one complaint for the master bulk lot was reported against an alternate sublot, for a false negative dat result.No trends were identified.No further investigation was performed on these incidents.The assignable cause of the discordant negative antibody screening and identification reactions obtained by the customer is sample related, the patient anti-e(rh3) antibody being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the e(rh3) antigen present on the reagent red blood cells.There is no evidence of any systematic failure of the ortho reagents to perform as intended.In mitigation of the discordant negative antibody identification results, the 0.8% resolve panel c and 0.8% surgiscreen instruction for use (ifu) states: for antibody detection and identification, different serological methods are optimal for different antibodies.No single antibody screening or identification method optimally detects all antibodies.In some low ionic strength test systems, certain anti-e and anti-k antibodies have been reported to be nonreactive.In addition, the ifu for the mts anti-igg gel card states: the use of enzyme-treated red blood cells with the mts anti-igg card may detect clinically insignificant antibodies.The mts buffered gel card is recommended when using enzyme treated cells.No other complaint of this type has been received from the customer site since the time of the reported event.
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