Recall Z-1388-2018— Life Technologies Corporation

Name: FDA recall Z-1388-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-07

Class II · Terminated

Class II FDA medical device recall by Life Technologies Corporation, initiated 2018-02-07, terminated 2019-05-08. It names one FDA 510(k) clearance: K990641. Product: Human Fetal Hemoglobin (HBF-1) FITC Conjugate. 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).

Recalling firm: Life Technologies Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-07
Terminated: 2019-05-08
Firm location: Frederick, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K990641 — CALTAG FETAL HEMOGLOBIN TESTCaltag Laboratories, Inc.·cleared 1999-09-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Human Fetal Hemoglobin (HBF-1) FITC Conjugate

Reason for recall

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.