Recall Z-2588-2018— bioMerieux, Inc.
Class II · Terminated
Class II FDA medical device recall by bioMerieux, Inc., initiated 2018-03-01, terminated 2025-12-09. FDA's recall record names no specific 510(k) clearance for this event. Product: VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). Reason: Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots..
- Recalling firm
- bioMerieux, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-01
- Terminated
- 2025-12-09
- Firm location
- Durham, NC, United States
Product description
VIDAS LH, Reference Numbers 30406 and 30406-01. Poduct Usage: VIDAS LH is an automated quantitative test for use on the VIDAS family instruments for the determination of human luteinizing hormone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay)
Reason for recall
Several complaints were received for invalid calibration with low calibrator S1 while using VIDAS LH. Internal tests confirmed a decrease of the strips signal overtime for specific lots.
Data sourced from openFDA. This site is unofficial and independent of the FDA.