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PathVysion
ABBOTT MOLECULAR INC. · Model 02J04-030 · UDI-DI 00884999001831
OYU
Prescription
3
510(k) clearances
4
Adverse events
1
Recalls
2
Facilities
Description
ProbeChek PathVysion HER-2/neu Cut-Off Control Slides
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-01 | Abbott Molecular, Inc. | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. |
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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.