Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 24123 |
| Brand Name: | BioPlex 2200 ANA Screen Control Set |
| Model: | |
| Affected: | Lot No. 50475 |
| Software version: | |
| Recalling Organisation: | Bio-Rad New Zealand Level 30 48 Shortland Street AUCKLAND 1010 |
| Contact Information: | 0508 805 500 |
| Manufacturer: | Bio-Rad (France) |
| Issue: | The manufacturer has identified that there is an error on the printed value assignment insert for the BioPlex 2200 ANA Screen Control (Catalogue No. 663-1131, UDI 00847865000055, Lot No. 50475). Product Support has determined that the mean values of the negative control for SS-A 60 and Centromere B were incorrectly listed as 0.2 Al on the printed value assignment insert for the BioPlex 2200 ANA Screen Control Set. The correct value for the negative control of SS-A 60 is 0.4 Al and the correct value of Centromere B is 0.3 Al. The mean values that were entered into your BioPlex 2200 System via the control assignment CD were correct and no further action is needed. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 30/1/2019 |
