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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of FETALSCREEN - Ortho-Clinical Diagnostics

DATE RECALL INITIATED:

January 9, 2007

PRODUCT / LOT NUMBER / EXPIRATION DATE:

FETALSCREEN Product Code 780540

Lot FS472 (expiration date: January 16, 2007)
Lot FS473 (expiration date: February 13, 2007)

MANUFACTURER:

Ortho-Clinical Diagnostics
Raritan, New Jersey

REASON:

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.

How does this notification differ from the Urgent Notification sent in January 2005?

In January 2005, consignees were instructed to consult with Medical Directors or appropriate Standard Operating Procedures (SOPs) for evaluation of results for previously tested patients. Internal testing results associated with this notification (dated Jan 9 2007) have shown no observed correlation between the weakened reactivity of the positive control and false negative patient's results. The test kit is able to detect an Rh-positive cell concentration of > 0.3% in a patient sample if the positive control results are valid. Based on these findings, evaluation of previously reported samples is not required.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002