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ReQuest
QUEST INTERNATIONAL, INC. · Model Anti-Sm · UDI-DI 00850487007265
LKP
Prescription
10
510(k) clearances
0
Adverse events
1
Recalls
14
Facilities
Description
Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-12-28 | Phadia Ab | All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investiga |
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