Agency classClass IIOur severity:High FDA (Devices)·Z-0428-2022·Announced 2022-01-05

VIDAS procalcitonin diagnostic test substrate error causes testing delays

Nationwide recall of VIDAS procalcitonin test kits for substrate defects that prevent testing and require retesting, potentially delaying diagnostic results.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall where a substrate defect prevents test operation. The recall is classified as High severity because it presents a risk of harm through diagnostic delays, with no illnesses or injuries currently reported.

Plain-English summary

bioMerieux, Inc. is recalling the VIDAS B.R.A.H.M.S. PROCALCITONIN PCT test kit (Reference 30450-01) nationwide. The recall involves approximately 28,430 units distributed to laboratories and healthcare facilities in the United States. The affected lot numbers are 1008603580, 1008748010, 1008888030, 1008584190, and 1008647850.

The recalled kits contain a substrate defect that prevents the test from running. When this defect occurs, the test cannot be completed, and users must repeat the test to obtain results.

The malfunction may lead to delayed diagnostic results. Laboratories and healthcare facilities using this product should review their inventory against the affected lot numbers. If affected kits are identified, they should be removed from use.

The recalled product

Product: VIDAS B.R.A.H.M.S. PROCALCITONIN PCT, REF 30450-01
Manufacturer: bioMerieux, Inc.
Category: Medical Device — Diagnostic Test
Hazard: substrate-error
delayed-diagnosis
Affected units: 28,430

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 03573026223601
Lot #s: 1008603580
1008748010
1008888030
1008584190
1008647850

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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