Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24276 |
| Brand Name: | FilmArray Gastrointestinal (GI) Panel |
| Model: | |
| Affected: | Part numbers: RFIT-ASY-0104 & RFIT-ASY-0116 |
| Software version: | |
| Recalling Organisation: | Medi'Ray New Zealand Ltd 53-55 Paul Matthews Road Albany Auckland 0632 |
| Contact Information: | 0800 633 472 |
| Manufacturer: | BioMerieux Inc |
| Issue: | The manufacturer has identified elevated rates of false positive results for Campylobacter and Cryptosporidium while using the BioFire GI Panel. Only the BioFire GI Panel kits with expiration dates ranging from 10/23/2019 - 02/20/2020 are affected. This is an expansion of previous Urgent Product Correction notice Ref #24276 The manufacturer has identified an increased risk of false positive results for Campylobacter and Cryptosporidium when using the BioFire GI Panel with expiration dates of 23 October 2019 onward. An investigation has determined that the false positive results are due to non-specific PCR amplification in the test, not from contamination with these two organisms. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 19/3/2019 |
