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POINTE SCIENTIFIC CK-MB
HORIBA INSTRUMENTS INCORPORATED · Model C7562-26 · UDI-DI 00811727010940
JHW
Prescription
1
510(k) clearances
12
Adverse events
2
Recalls
6
Facilities
Description
The CK-MB Reagent is for the quantitative determination of the isoenzyme Creatine Kinase-MB (CK-MB) in serum. For in vitro diagnostic use only.
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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