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CK-MB Test
STANBIO LABORATORY, L.P. · Model 0980-103 · UDI-DI 00657498000748
JHW
Prescription
10
510(k) clearances
12
Adverse events
2
Recalls
6
Facilities
Description
For the Quantitative Determination of Creatine Kinase-MB (CK-MB) in Serum for Manual and/or Automated Procedures.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-12-12 | Zimmer 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 |
| 2010-11-22 | Medtest Holdings, Inc. | Incorrect control range in product labeling |
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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.