Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0424-2022·Announced 2022-01-05

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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.
Category: Medical Device — In Vitro Diagnostic
Hazard: substrate-error
test-failure
Affected units: 1,818

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.

Part of a larger recall action

This product is one of 16 recalled by bioMerieux, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 16 products in this recall →

Same manufacturer · bioMerieux, Inc.

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