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FDA Recall of FETALSCREEN


Posted on 2007-02-15 11:53:00



Further testing of FetalScreen by the FDA inline with the notice issued on Jan 9th, confirmed that the testing kit would be fully recalled

On the FDA's website they gave the reason as:
"Ortho-Clinical Diagnostics has received reports of weak or negative reactivity with the positive control provided in FETALSCREEN lots FS472 and FS473. OCD has confirmed this issue and has determined that the positive control is not consistently producing the expected results described in the package insert.

During OCD’s investigation, samples were tested at Rh-positive cell concentrations that were less than or equal to the concentration of the positive control. OCD has determined that the positive control is not predictive of the performance of the kit. Samples with Rh positive cell concentrations lower than the positive control continue to yield positive results (i.e. no false negative results were observed).

Consignees have been asked to discontinue using and discard any remaining kits of FETALSCREEN Lots, FS472 and FS473 and use an alternative method for detection of D (Rh) positive fetal red blood cells in the maternal circulation. Until a root cause is identified, OCD will be unable to supply replacement products."



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