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CK-MB Liqui-UV®

STANBIO LABORATORY, L.P. · Model 2980-430 · UDI-DI 00657498001547

JHW Prescription
10
510(k) clearances
12
Adverse events
2
Recalls
6
Facilities

Description

For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures.

Recalls

DateFirmReason
2017-12-12Zimmer Biomet, Inc.A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that
2010-11-22Medtest Holdings, Inc.Incorrect control range in product labeling

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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.