FDA Device Intelligence
Home › STRECK, INC. › Para 12® Plus

Para 12® Plus

STRECK, INC. · Model 230592 · UDI-DI 30844509000199

JCN Prescription
1
510(k) clearances
2
Adverse events
3
Recalls
9
Facilities

Description

Para 12® Plus is an assayed hematology control for evaluating the accuracy and precision of hematology instruments that provide a white blood cell differential.

Recalls

DateFirmReason
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
2025-06-04Siemens Healthcare Diagnostics, Inc.Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.