Hcg Stat Elecsys Cobas E 100 V2, Troponin I Elecsys Cobas E 100, Troponin T Hs Stat Elecsys, Cobas E 100, Myoglobin Stat Elecsys Cbas E 100 (2018-06-05)

Recall Summary Roche Diagnostics is recalling certain HCG STAT, Troponin I, Troponin T hs STAT, and Myoglobin STAT test kits for use with Elecsys and cobas e 100 laboratory analyzers across Canada because these diagnostic tests may produce inaccurate results. This recall affects hospitals, clinics, and diagnostic laboratories that use these specific testing systems.

Reason
Medical devices
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2018-07-06
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/513bb606-26d6-4c34-a9a1-5d73ce62b0c1