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U.S. Department of Health and Human Services

Medical Devices

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Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test, and AccuProbe Mycobacterium Avium Complex Culture Identification Test

Recall Class: Class I

Date Recall Initiated: December 30, 2008

Products:

Product #1: AccuProbe Group B Streptococcus Culture Identification Test
Product #2: AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test
Product #3: AccuProbe Mycobacterium Avium Complex Culture Identification Test

Model Number Lot Numbers
Product #1: 2820 554077, 551345, 556007, 556185,
555368, 554864, 556421, 555167,
555096, 555166, 556184, 554524
Product #2: 2860 554628, 555170, 556204
Product #3: 2835 555767

These products were manufactured from September 24, 2008 through October 31, 2008 and distributed from October, 2008 through December, 2008.

Use:

Product #1: AccuProbe Group B Streptococcus Culture Identification Test

The test is primarily used to screen pregnant women for bacteria called group B streptococcus (group B strep). Group B strep causes life-threatening infections in pregnant women, newborns, the elderly, and adults with other illnesses.

Pregnant women who test positive for group B strep at 35 to 37 weeks and who are carriers (as identified by the U.S. Centers for Disease Control and Prevention), are given an antibiotic during delivery to prevent group B strep from being transferred to their newborn during vaginal birth. This test may also be used in conjunction with gynecologic surgery (procedures performed through the vagina rather than through the abdomen).

Product #2: AccuProbe Mycobacterium Avium Complex Identification Test.

This test is used to identify Mycobacterium Avium Complex. People who are infected with Mycobacterium Avium Complex usually have immunocompromising diseases such as Acquired Immunodeficiency Syndrome (AIDS).

Product #3: AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test

This laboratory test is used to identify people who have tuberculosis.

Recalling Firm:
Gen-Probe, Inc.
10210 Genetic Center Drive
San Diego, California 92121

Reason for Recall:

The affected kits may contain tube components that are partially empty or empty of solution. Possible false-negative results may occur. This may cause serious adverse consequences and/or death.

Public Contact: Customers may contact the company’s technical support at 1-888-484-4747, by FAX at 1-858-410-8250 or by email at technicalsupport@genprobe.com.

FDA District: Los Angeles

FDA Comments:

Gen-Probe is recommending that customers DISCONTINUE using the identified batch (lot) numbers listed above.

For customers who used these batches and obtained negative results, the firm recommends that the referring physician be notified about the possibility of a false negative result. Customers will receive a Customer Response Form to complete.

The company requested customers to separate the affected kits from other kits in their inventory that were listed on the Customer Response Form. After customers completed the separation, they were asked to:

  • destroy all affected kits (partial and/or full kits)
  • document the amount of affected kits destroyed on the Customer Response Form
  • update Gen-Probe with the amount of affected kits that have been destroyed by phone, FAX, or email.
  • sign and return the completed form to Gen-Probe by :
  • contact Technical Support for replacement kits and additional information at 1-888-484-4747 or by email at technicalsupport@genprobe.com.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program either online, by regular mail or by FAX.