VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated S
Check against the official notice below — it lists the full affected range.
Ortho-Clinical Diagnostics has recalled VITROS Chemistry Products VALP Reagent Pack (Catalog #6801710) due to negative bias results when using VITROS VALP Reagent, GEN 25. The affected product was distributed worldwide, including in the United States and numerous other countries. A total of 9,014 units were distributed, with 6,798 in the U.S. and 2,216 outside the U.S. Six specific lot numbers are affected, with expiration dates ranging from September 2017 through April 2019.
The recall affects lots numbered 25-5263, 25-5503, 25-5727, 25-5974, 25-6067, and 25-6393. The source document does not specify what actions affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Negative bias results when using VITROS VALP Reagent, GEN 25.
Reason for recall: Negative bias results when using VITROS VALP Reagent, GEN 25. 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. Quantity: 9014 Total (U.S. = 6798; OUS: U.S. = 2216) Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.