Catalog Number OPAX032 SMN10445973 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Siemens healthcare diagnostics has observed a reduced once-opened stability and a reduced on-board stability for the affected lot 802907632 that may result in erroneously reduced or elevated homocysteine.This stability issue may lead to a higher than expected lot-to-lot variation and impaired product performance.Urgent medical device correction (umdc) (b)(4) was sent to customers in the united states on january 11, 2017 and corresponding urgent field safety notice (ufsn) (b)(4) was sent to all outside us customers who have been shipped the impacted lot, 802907632.The umdc and ufsn titled "n latex hcy and n latex hcy (bcs® xp) lot 802907632 does not meet once-opened and onboard stability claims" and instructs customers to discontinue use and to discard the lot.
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Event Description
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Discordant low homocysteine (hcy) results were obtained with lot 802907632 in a lot to lot comparison study with a newer lot 802908369 on the bnii instrument.Patient results were reported to the physician(s).Quality control for both lots,802907362 and 802908369, were within the laboratory ranges.There are no reports of patient intervention or adverse health consequences due to the discordant low hcy results.
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Search Alerts/Recalls
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