Biofire Blood Culture Identification 2 (bcid2) Panel
- Recalling firm
- Medi'Ray New Zealand Ltd
- Product
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel. [Device]. Affected: Lots# 0004102964, 0004102996, 0004102946, 0004102956, and 0004102998 - All unexpired lots when used with specific BACT/ALERT® Blood Culture Bottles.
- Reason
- The manufacturer has identified an increased risk of false positive Serratia marcescens results when the BIOFIRE BCID2 Panel is used with certain lots of BACT/ALERT Culture Bottles., The presence of non-viable organism does not compromise the intended function of the blood culture bottles (culturing viable microorganisms). However, the BIOFIRE BCID2 Panel detects nucleic acid from viable and non-viable organisms alike.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-03-31
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/7dd7afee-3baf-4967-aba7-bbc647207bd0