KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in pati
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems, Inc. is recalling Roche cobas 4800 HPV AMP/DET kits due to a formulation error in the HPV Master Mix reagent. During manufacturing, an error in the tare weight used for the carboy resulted in incorrect formulation of the reagent that was packaged into four specific kit configurations (US-IVD 240T and 960T, and CE-IVD 240T and 960T). The recall affects 350 US-IVD kits and 441 CE-IVD kits with specific lot numbers identified by Roche.
The affected kits were distributed worldwide, including throughout the United States and to 25 other countries. The specific lot numbers for US-IVD kits are R13814 and R15785 (material number 05232880190), and for CE-IVD kits are R15771 and R15304 (material numbers 05235898190, 05235901190, and 05235910190). The source document does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina
Reason for recall: During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas¿ 4800 HPV Master Mix reagent that was packaged in four (4) cobas¿ 4800 AMP/DET kits, US- and CE-IVD (240 and 960 test kit configurations). Examination of the batch production record of the material revealed there was an error in the tare weight used for the carboy during the fina Distribution: Worldwide Distribution - USA (nationwide) including the countries of Austria, Australia, Belgium, Brazil, Czech Rep, Canada, Croatia, Columbia, Denmark, Dominican Republic, Germany, Ecuador, France, Japan, Greenland, Mexico, Italy, New Zealand, Netherlands, Peru, Norway, Singapore, Romania, South Africa, Spain, South Korea, Sweden, Switzerland and UK. Quantity: US-IVD: 350 Kits; CE-IVD: 441 KITS Lot/code info: US-IVD: Material number 05232880190 Lot Number R13814, R15785 CE-IVD: Material Number: 05235898190 05235898190 05235901190 05235910190 Lot Number R15771, R15304
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.