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Architect I System - TOXO IGM Kit
- Starting date:
- November 17, 2016
- Posting date:
- December 5, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-61308
Reason
For the ARCHITECT Toxo IgM assay, an increase in grayzone and/or false reactive results have been observed for samples from immunocompromised patients or newborns as well as cord blood samples for the lot numbers enclosed. These sample types share the commonality of low total immunoglobulin M (IgM) titer.
Affected products
Architect I System - TOXO IGM Kit
Lot or serial number
64245LI00
64248LI00
66063LI00
66066LI00
67003LI00
67006LI00
68443LI00
68444LI00
69252LI00
69253LI00
70171LI00
70174LI00
Model or catalog number
6C20-25
6C20-35
Companies
- Manufacturer
-
Abbott GmbH and Co. K.G.
Max Planck Ring 2
Wiesbaden
65205
GERMANY