Z-1687-2018Class II
ADVIA Centaur Cyclosporine
Siemens Healthcare Diagnostics Inc. / initiated 2018-01-02 / Terminated / root cause: labeling and UDI
Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur Cyclosporine on . FDA classified it as Class II and gives the reason as "The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1687-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Product
- ADVIA Centaur Cyclosporine
- Product code
- MKW Cyclosporine
- Reason for recall
- The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere
- Root cause tag
- labeling and UDI
- FDA root cause
- Error in labeling
- Action
- Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
- Distribution
- Nationwide and Canada, Mexico, and Thailand
- Product codes and lots
- ADVIA Centaur¿ Cyclosporine; Cyclosporine; SMN 10335448 Lot codes: ADVIA Centaur CSA Lot # 38182025 64432025 98554025 58299030 25547030 30153031 77934031 97170031
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1668-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1669-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1670-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1671-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1672-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1673-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1674-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1675-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1676-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1677-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1678-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1679-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1680-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1681-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1682-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1683-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1684-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1685-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1686-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1687-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1688-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1689-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1690-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1691-2018 | Class II | Terminated | Voluntary: Firm initiated |
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