Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Enforcement
- Recall Number
- Z-1235-2019
- Event ID
- 82521
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 8, 2019
- Initiation Date
- December 7, 2018
- Classification Date
- April 26, 2019
- Termination Date
- April 27, 2020
- Address
- 333 Coney St, N/A, East Walpole, MA, 02032-1516, United States
Description
Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
Positive bias anti-thyroglobulin with ADVIA Centaur aTG kit lots ending in 316 and lower and Atellica IM aTG kit lots ending in 317 and lower when compared to the standardization to World Health Organization (WHO) Reference Preparation MRC 65/93 stated in the Instructions for Use (IFU).
Lot Number/Exp. Date: kit lots ending in 317 and lower 72259303 12/13/2018 87903305 1/12/2019 94908307 2/11/2019 96439307 2/11/2019 16824309 3/14/2019 25822309 3/14/2019 28942311 4/27/2019 55978313 5/27/2019 70389317 6/29/2019
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1489 kits