VIDAS PRG Progesterone, REF 30409-01
Check against the official notice below — it lists the full affected range.
bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone (REF 30409-01) distributed nationwide in the United States due to a substrate error. The error prevents the test from running properly, which means users cannot complete the test and must run another one, potentially causing delayed results.
The affected units have the following lot numbers: 1008685490, 1008766980, 1008775630, 1008873180, and 1008911240 (UDI 03573026064952). The source document does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
Reason for recall: bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test. Distribution: US Nationwide distribution. Quantity: 1818 units Lot/code info: UDI 03573026064952, Lot #s: 1008685490, 1008766980, 1008775630, 1008873180, 1008911240
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.