FDA Recalls Blood Culture Identification Panel for False Negative Results
BioFire Diagnostics is recalling 29 FilmArray Blood Culture Identification Panel kits distributed nationwide due to false negative test results caused by a pouch manufacturing error.
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is diagnostic failure (false negative results), which poses a risk of harm through missed clinical diagnoses. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a score of 3.
Plain-English summary
BioFire Diagnostics, LLC is recalling 29 FilmArray Blood Culture Identification (BCID) Panel kits (FDA Class II recall). These kits are used to identify bacteria and other microorganisms in blood cultures for diagnostic purposes.
The company received complaints of false negative results (dropouts) with the blood culture identification panel. The issue is potentially caused by a pouch manufacturing error.
The affected kits were distributed nationwide to healthcare facilities in Florida, Michigan, New Jersey, Ohio, Virginia, and Wisconsin. The specific lot numbers are Kit Lot# 0868221, Pouch Lot# 194Z21, and Batch 003.
The recalled product
- Product
- FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
- Manufacturer
- BioFire Diagnostics, LLC
- Affected units
- 29
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 (5)
- Part No: RFIT-ASY-0126 / UDI: 00815381020086
- Part No: RFIT-ASY-0127 / UDI: 00815381020093
- Kit Lot# 0868221
- Pouch Lot# 194Z21
- Batch 003
Distribution
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