Medical Diagnostic Device Recalled Due to Temperature and Time Excursions
Biomerieux Inc. is recalling PPM LOMBARD diagnostic products due to storage temperature and time conditions being exceeded during distribution, which compromises the product's guaranteed performance.
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 recall of a medical diagnostic device affected by storage condition excursions. While no illnesses or injuries have been reported, compromised performance of a diagnostic device presents a risk of inaccurate test results that could affect patient care.
Plain-English summary
Biomerieux Inc. is recalling PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT (Catalog C6045-IR), a medical diagnostic device used for microbial identification. The recall affects 60 units with batch number 1009524320 and UDI code 03573026319946, distributed nationwide in the United States.
The recall was initiated because temperature and time storage conditions were exceeded during distribution. As a result, the manufacturer cannot guarantee that the products will perform as originally designed.
Patients and healthcare providers should discontinue use of affected devices from this batch and contact the manufacturer or distributor for guidance. Healthcare facilities should check their inventory for units matching batch number 1009524320 and take appropriate action based on manufacturer guidance.
The recalled product
- Product
- PPM LOMBARD PRODUCTS CT&IR&DB-TSA + L & P80 10PLT, CATALOG C6045-IR
- Manufacturer
- Biomerieux Inc
- Affected units
- 60
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 (2)
- UDI/DI 03573026319946
- Batch Numbers: 1009524320
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 94 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 94 products in this recall →Related recalls
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