Recall Z-1388-2018 ยท GHQ Stain, Fetal Hemoglobin
Life Technologies Corporation
Human Fetal Hemoglobin (HBF-1) FITC Conjugate
| Date | Feb 7, 2018 |
| Status | Terminated |
| Reason | Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual bright staining in the controls and patient samples which could potentially lead to erroneous results (i.e. false positives) |
| Root cause | Use error |
| Action | All consignees which have purchased the Human Fetal Hemoglobin FITC antibody including facilities/customers that have shipped the lots outside of their facility will be notified via certified mail to check inventory to see if affected product is on hand. Consignees instructed to discontinue use and discard per internal procedure. The effectiveness check will begin 10 days after the distribution date of the Medical Device Recall Notification. The field removal is considered effective when 10% of the affected customers acknowledge receipt and understanding of the notification instructions. |
| Distribution | MI, CA, IL, TX, SC, NY, MN, DE, NJ, WA , OR, IN, MA, DE, FL, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990641 | CALTAG FETAL HEMOGLOBIN TEST Caltag Laboratories, Inc., Sep 17, 1999 |