Creatine Kinase (CK)
Brand(s)
Last updated
Summary
Product
Creatine Kinase (CK)
Issue
Medical devices - Performance
What to do
Contact the ROCHE CARE CENTER at 1-877-273-3433 or (450) 686-7111 and by e-mail at LAVAL.TECHINFO@ROCHE.COM.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Creatine Kinase (CK) | 755471 | 07190794190 |
Issue
Roche received complaints from US customers for Creatine Kinase (CK) lot 755471 (expired June-2024) on cobas c 311/501/502 and INTEGRA 400 plus about abnormal calibration signals, flagged calibrations (Sens.E) and control recovery issues. Subsequent investigation identified a positive bias at the lower measuring range and a negative bias at the higher measuring range. The issue affects a small number of cassettes of the mentioned lot.
Recall Start Date: August 19, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Roche Diagnostics Gmbh
Sandhoferstrasse 116, Mannheim, Germany, 68305
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75993
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