cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems, Inc. is recalling cobas PCR Urine Kits, cobas PCR Female Swab Kits, and cobas PCR media kits because the cobas PCR media 4.3 mL containers have been leaking. The company received numerous complaints about leaking media from different lots of these products. The recall affects 84 kit batches distributed nationwide, including specific lot numbers for each product type.
The affected products include lot S01487 and earlier for the cobas PCR Female Swab Sample Kit, and lot S01885 and earlier (except lot number S01884) for the cobas PCR Urine Sample Kit. The recall involves 48 IVD kit batches, 31 US kit batches, and 6 JPN-IVD kit batches. According to the recall record provided, no remedy is specified for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits.
Reason for recall: Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿ PCR media kits. Distribution: Nationwide Distribution Quantity: 84 kit batches Lot/code info: K110923 cobas PCR Female Swab Sample Kit 05170516190 Lot S01487 and earlier cobas PCR Urine Sample Kit 05170486190 Lot S01885 and earlier (except lot number S01884) IVD: 48 kit batches US: 31 kit batches JPN-IVD:6 kit batches
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.