Z-1669-2018Class II
Dimension Free Thyroxine (FT4L) Flex reagent cartridge
Siemens Healthcare Diagnostics Inc. / initiated 2018-01-02 / Terminated / root cause: labeling and UDI
Siemens Healthcare Diagnostics, Inc. began a recall of Dimension Free Thyroxine (FT4L) Flex reagent cartridge 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-1669-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Product
- Dimension Free Thyroxine (FT4L) Flex reagent cartridge
- Product code
- CEC Radioimmunoassay, Free Thyroxine
- 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
- FT4L, radioimmunoassay, free thyroxime, RF610, SMN# 10464523 Lot codes: EA7276 EC7304 EC7333 EA7346 EB8010 EA8037 EA8065 EB8086 EB8108 EA8130 EA8156 EA8179 EA8205 EA8233 FD8254
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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