Z-1688-2018Class II
ADVIA Centaur DHEA-SO4
Siemens Healthcare Diagnostics Inc. / initiated 2018-01-02 / Terminated / root cause: labeling and UDI
Siemens Healthcare Diagnostics, Inc. began a recall of ADVIA Centaur DHEA-SO4 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-1688-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Product
- ADVIA Centaur DHEA-SO4
- Product code
- JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- 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¿ DHEA-SO4; radioimmunoassay, dehydroepiandrosterone (free and sulfate); SMN 10282227 ADVIA Centaur DHEA-S Kit Lot # 00119053 14041053 80449053 90520053 29750054 30423054 39155054 50533054 63267055 68936055 79273055 86427055 06402057 07109057 14187057 37499057
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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