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Terminated

The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit

FDA Recall Z-2649-2017 · Posted 2017-06-29

Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeJHW
Date Initiated2010-11-22
Date Terminated2017-07-24
Product Quantity5 kits

Reason for Recall

Incorrect control range in product labeling

Firm Action

On 11/22/2010, 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

Employee error

Distribution Pattern

FL, AR, NICARAGUA, KOREA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942958CREATINE KINASE MB DETERMINATION (UV)Biochemical Trade, Inc. · 1994-11-21

Official Source

View FDA Recall →

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

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