Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 23526 |
| Brand Name: | Pastorex Meningitis |
| Model: | |
| Affected: | Lot numbers - 64160551, 64175493, 64169521 |
| Software version: | |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad Laboratories Inc |
| Issue: | Recent customer complaints concerning unusual high rates of positive agglutination with the R4 reagent, Streptococcus pneumoniae latex, not confirmed by another technique raised concern on the product. Quality control tests performed showed that the reagent R4 has an unspecific agglutination with sterile physiological water. This is observed with the reagent R4 only. Update Notice: As the final root cause has not yet been determined by the manufacturer, all lots currently in production are impacted by the defect. In order to limit the impact on our customers the manufacturer has decided to release all future lots (from Lot # 64186384 onwards) with a restriction of use on the R4 reagent until the corrective action can be applied. A caution label will be stuck to each box and customer notice supplied to users. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/8/2018 |
