H6: investigation summary product 347206 (cd138 pe, clone mi15, asr) lot 9350474 manufactured from subassembly 91-0493 batch 9304853, was manufactured according to specifications.The review of the manufacturing batch history record (bhr) or release records indicates product perform as intended per bd specifications.Retain sample of product 347206 (cd138 pe, clone mi15, asr) lot 9350474 was evaluated under subassembly 91-0493 batch 9304853 by flow cytometry special instruction testing.Multiple myeloma cell line rpmi 8226 was used as target for cd138 staining, given its known positive expression of this marker (matsui et al, 2004).Root cause is not determined.Customer reported that product 347206 (cd138 pe, clone mi15, asr) lot 9350474 is having a performance issue of dim staining.Bd specifications for this cd138 pe product lot-to-lot fluorescence variability against a reference lot is -50% to +100%.Evidence demonstrates manufacturing process was performed according to requirements and product met applicable specifications without discrepancy.Additionally, testing by flow cytometry did not confirmed a functional performance of this product.Based on this investigation, the claim is not confirmed, and no further actions are deemed necessary at this time.H3 other text : see h.10.
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