Obstetricians: Gen-Probe Recalls ACCUPROBE Kits
On December 30, 2008, Gen-Probe, Inc., notified its customers and distributors that it was voluntarily recalling specific lot numbers of its ACCUPROBE Group B Streptococcus (GBS) kit, ACCUPROBE Mycobacterium tuberculosis Complex (TB Complex) kit, and ACCUPROBE Mycobacterium avium Complex (M. avium Complex) kit.
Specific batches of these kits contain a random manufacturing defect that can result in the possible reporting of a false-negative.
Gen-Probe advises that all customers discontinue using the affected kits. For customers who have already used the batches and obtained negative results, Gen-Probe recommends notifying the referring physician about the possibility of a false-negative result.
For additional information on the specifics of this recall, please contact Gen-Probe’s Technical Support at (888) 484-4747 or technicalsupport@gen-probe.com.
The Doctors Company encourages physicians to determine whether any patients in their practice who tested negative within the specified time frame are at risk for a false-negative result. The physician should then determine a follow-up plan and communicate it to the patient.
If the risk managers within the Department of Patient Safety can assist you, please call us at (800) 421-2368, extension 1243.
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The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider in light of all circumstances prevailing in the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.