Z-1681-2018Class II
IMMULITE 2000/IMMULITE 2000 XPi Gastrin
Siemens Healthcare Diagnostics Inc. / initiated 2018-01-02 / Terminated / root cause: labeling and UDI
Siemens Healthcare Diagnostics, Inc. began a recall of IMMULITE 2000/IMMULITE 2000 XPi Gastrin on . FDA classified it as Class II and gives the reason as "Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, 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-1681-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Siemens Healthcare Diagnostics Inc.
- Product
- IMMULITE 2000/IMMULITE 2000 XPi Gastrin
- Product code
- CGC Radioimmunoassay, Gastrin
- Reason for recall
- Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
- 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
- Gastrin, Gastrin (IMMULITE/IMMULITE 1000, LKGA1), (IMMULITE 2000/IMMULITE 2000 XPi, LKGA2) Lot codes: 251 252 253 254 255
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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