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Terminated

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s): L7572. For the in vitro quantitative kinetic determination of lactate dehydrogenase activity in serum.

FDA Recall Z-2165-2017 · Posted 2017-05-26

Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeCFJ
Date Initiated2011-07-08
Date Terminated2017-06-02
Product Quantity716.146L total

Reason for Recall

Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met.

Firm Action

Pointe Scientific issued field communication alerting end users of the corrected stability claim. To date the firm has sent individualized communications to 100% of end users that received the product and posted the notification to the company website.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc., · 1997-10-08

Official Source

View FDA Recall →

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

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