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.
What this means for you
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
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.
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