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Terminated

Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit comprised of two reagents an R 1 Buffer and R2 CK enzyme solution. Intended Use: For the kinetic quantitative determination of creatine kinase activity in serum.

FDA Recall Z-2650-2017 · Posted 2017-06-29

Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeCGS
Date Initiated2011-10-19
Date Terminated2017-07-24
Product Quantity319.922 L

Reason for Recall

Linear performance information in product insert does not match that listed in the approved premarket notification

Firm Action

Pointe Scientific/Technical Bulletin sent notifications on October 19, /2011, TECHNICAL BULLETIN notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972155CREATINE KINASE (CK)Stanbio Laboratory · 1997-07-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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