Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Reported: January 29, 2020 Initiated: July 22, 2019 #Z-0830-2020
Product Description
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366
Reason for Recall
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 10,928 kits
- Distribution
- Nationwide Foreign: Armenia¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Czech¿Republic¿ Denmark¿¿¿¿¿¿¿¿ Egypt¿¿¿¿¿¿¿¿¿¿ France¿¿¿¿¿¿¿¿¿ Georgia¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Hungary¿¿¿¿¿¿¿¿ Iran¿¿¿¿¿¿¿¿¿¿¿ Ireland¿¿¿¿¿¿¿¿ Israel¿¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ Jordan¿¿¿¿¿¿¿¿¿ Lithuania¿¿¿¿¿¿ Nepal¿¿¿¿¿¿¿¿¿¿ Netherlands¿¿¿¿ Norway¿¿¿¿¿¿¿¿¿ Pakistan¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Qatar¿¿¿¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Russian¿Fed.¿¿¿ Serbia¿¿¿¿¿¿¿¿¿ Slovakia¿¿¿¿¿¿¿ Slovenia¿¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Sudan¿¿¿¿¿¿¿¿¿¿ Sweden¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿ Vatikancity¿¿¿¿
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325366. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 10,928 kits.
Why was this product recalled? ▼
Homocysteine Assay May Cause Elevated Results in the Folate Assay
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0830-2020.
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