ROCHE MOLECULAR SYSTEMS, INC. COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD; HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) GROUP M AND O RNA, HIV-2 RNA, HCV
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Catalog Number 05969492190 |
Device Problems
False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
Insufficient Information (4580)
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Event Date 03/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No issues were identified with kit lots e18109, e16111, e15557, 336610 during the course of the investigation.The material number for the cobas taqscreen mpx test, v2.0 us-ivd: 05969484190.(b)(4).
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Event Description
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A customer in (b)(6) reported the possibility of a (b)(6) with the cobas taqscreen mpx test, v2.0, which was used to test donation(s) transfused into a thalassemic recipient.(b)(6).The customer did not provide other information or evidence that indicates that the recipient's (b)(6) is related to the previously tested blood donations.
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Search Alerts/Recalls
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