Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 20108 |
| Brand Name: | Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 100 Test Kit |
| Model: | 3P25-25 and 3P25-26 |
| Affected: | Lot Nos: 6103U100 55946U100 58927U100 58927U101 63010U100 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara California 95054 United States of America |
| Contact Information: | |
| Manufacturer: | |
| Brand Name: | Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 500 Test Kit |
| Model: | 3P25-35 and 3P25-36 |
| Affected: | Lot Nos: 59259U100 55957U100 59904U100 and 6207U100 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara California 95054 United States of America |
| Contact Information: | |
| Manufacturer: | |
| Brand Name: | Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 100 Test Kit |
| Model: | 3P25-25 amd 3P25-26 |
| Affected: | Lot Nos: 62019U100 62021U100 63139U100 62025U100 62026U100 and 62364U100 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara California 95054 United States of America |
| Contact Information: | |
| Manufacturer: | |
| Brand Name: | Abbott ARCHITECT STAT HighSensitive Troponin -I Reagent Kit 500 Test Kit |
| Model: | 3P25-35 and 3P25-36 |
| Affected: | Lot Nos: 62022U100 63108U100 63137U100 62255U100 and 63051U100 |
| Software version: | |
| Recalling Organisation: | Abbott Diagnostics 5440 Patrick Henry Drive Santa Clara California 95054 United States of America |
| Contact Information: | |
| Manufacturer: | |
| Issue: | Manufacturer has identified a potential for increased calibration failures prior to the expiraton date for p specific lots of ARCHITECT STST High Sensitive Troponin-1 reagent. Cstomers are instructed to either: 1. Once an alternate reagent lot is available the customer is being instructed to destroy remaining inventory of affected list.Or 2. Change the expiration date of impacted lots. |
| Recall action type: | Correction |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 2/5/2016 |
