FDA Recalls VIDAS PRG Progesterone Test Kits for Substrate Error
bioMerieux is recalling 1,818 units of VIDAS PRG Progesterone test kits due to a substrate error that prevents the tests from running properly, causing delayed results when patients need repeat testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recall with a substrate error that prevents proper test execution, but no reported illnesses, injuries, or hospitalizations. The primary impact is operational—test failure requiring repeat testing—rather than direct patient harm.
Plain-English summary
bioMerieux, Inc. is recalling 1,818 units of VIDAS PRG Progesterone test kits (REF 30409-01) that are distributed nationwide across the United States.
A substrate error in these test kits prevents the tests from running properly. When this error occurs, the test cannot be completed and users must run another test to obtain results, potentially delaying diagnosis.
The FDA has classified this as a Class II recall. The affected lot numbers are 1008685490, 1008766980, 1008775630, 1008873180, and 1008911240. Healthcare facilities and laboratories that have received kits from these lots should contact bioMerieux or their supplier for replacement or further guidance.
The recalled product
- Product
- VIDAS PRG Progesterone, REF 30409-01
- Manufacturer
- bioMerieux, Inc.
- Hazard
- substrate-error
- test-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI 03573026064952
- Lot #s: 1008685490
- 1008766980
- 1008775630
- 1008873180
- 1008911240
Distribution
Distributed nationwide across the United States.
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