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) pp17-005.A.Us was sent to customers in the united states on january 11, 2017 and corresponding urgent field safety notice (ufsn) br-01117_ous 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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