Vidas LH recall
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…
Why was Vidas LH recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Reference No. 30406-01, Lot No. 1006041520 (Exp. Date 10/06/2018); Reference No. 30406, Lot No. (Exp. Date): 1005940920 (08/06/2018), 1006041540 (10/06/2018), 1006212740 (12/21/2018), 1006274770 (01/29/2019)
- 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…
- Recalling firm
- bioMerieux, Inc.
- Quantity
- 5,429 units
- Distribution
- Worldwide Distribution - US Nationwide in the state of Arizona and North Carolina. Distributed internationally to Algeria, Algeria, Angola, Argentina, Bahrain, Bangladesh, Belarus, Bosnia-Herz., Brazil, Bulgaria, Burkina Faso, Cameroon, Canada, Chad, Colombia, Congo, Costa Rica, Cote d'Ivoire, Czech Republic, Djibouti, Dutch Antilles, Ecuador, Egypt, Estonia, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Mali, Mauretania, Mexico, Morocco, Mozambique, Myanmar, Netherlands, Nicaragua, Nigeria, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, Republic of Congo, Romania, Russia, Saudi Arabia, Senegal, Serbia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, Uruguay, United Arab Emirates.
- Recall date
- August 8, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)