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Pointe Scientific CK-MB
HORIBA INSTRUMENTS INCORPORATED · Model C7563-90 · UDI-DI 00811727018649
JHW
Prescription
1
510(k) clearances
12
Adverse events
2
Recalls
6
Facilities
Description
Pointe Scientific Creatine Kinase MB. 3 x 24 ml R1 and 3 x 6 ml R2. For the Quantitative Determination of Creatine Kinase-MB in Serum for Manual and/or Automated Procedures. Rx 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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