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Complete and submit the report Online Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S

High-Risk Diagnosis Codes Z72.51 High risk heterosexual behavior Z72.52 High risk homosexual behavior Z72.53 High risk bisexual behavior Z77.29 Exposure to hazardous substances Z77.9 Other exposure hazardous to health Z91.89 Other specified personal risk factors Z92.89 History of other medical treatment Low-Risk Diagnosis Codes Z01.411 Routine gynecological exam with abnormal findings Z01.419 Routine gynecological exam without abnormal findings Z12.4 Cervical cancer screening Z12.72 Vaginal cancer screening Z12.79 Screening for other genitourinary malignancies Z12.89 Screening for malignancy at other sites Pre-existing Diagnosed Conditions R87.622 (Low-grade squamous intraepithelial lesion) R87.610 (Atypical squamous cells of undetermined significance) Providers should verify coding updates annually, as diagnosis code qualifiers may shift due to clinical guideline revisions

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Record the device time, should you use 97813 and 97814