Cortisol Saliva Luminescence Immunoassay The IBL recall
Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic…
Why was Cortisol Saliva Luminescence Immunoassay The IBL recalled?
Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in comparison to NIST cortisol standard.
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?
In USA RE62119 Lot # LCL129 exp. date: 2017-11-30, RE62119 Lot # LCL133 exp. date: 2019-03-31, and RE62111 Lot # LCL130 exp. date: 2018-03-31. OUS Lot 131, Lot 132
- Product
- Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is intended for the in-vitro diagnostic…
- Recalling firm
- Tecan US, Inc.
- Quantity
- 870 (USA) 180 (OUS)
- Distribution
- Worldwide distribution; US distribution to states of: GA, IA, LA, MA, MN, OR, PA, SC, and UT; and countries of: Germany, Finland, Switzerland, France, Austria, Denmark, Poland, Norway, Belgium, Netherlands, Italy, Canada, South Africa, Russia, and Japan.
- Recall date
- September 5, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)