VITROS Chemistry Products VALP Reagent Pack. For in recall
VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only.…
Why was VITROS Chemistry Products VALP Reagent Pack. For in recalled?
Negative bias results when using VITROS VALP Reagent, GEN 25.
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?
Affected Lots/Expiry: 25-5263 2017-09-09; 25-5503 2018-01-06; 25-5727 2018-04-30; 25-5974 2018-08-14; 25-6067 2018-11-05; 25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748
- Product
- VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only.…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 9014 Total (U.S. = 6798; OUS: U.S. = 2216)
- Distribution
- Worldwide distribution- US (Nationwide) and countries of: Australia, Belgium, Bermuda, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands and United Kingdom.
- Recall date
- February 27, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)