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Autoscreen I MS KDY/STM 48 Test

SCIMEDX CORPORATION · Model 1248L · UDI-DI 00813545021986

DBL
10
510(k) clearances
1
Adverse events
1
Recalls
8
Facilities

Recalls

DateFirmReason
2008-07-29Bio-Rad LaboratoriesThe Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.