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Terminated

Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

FDA Recall Z-2586-2017 · Posted 2017-06-14

Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeCIG
Date Initiated2012-03-13
Date Terminated2017-07-24
Product Quantity270.36 L

Reason for Recall

Decrease reactivity of R 1 component.

Firm Action

On 3/13/2012 and 5/3/2012, Field Correction Notice notifications were sent to the affected consignees via e-mail/fax. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution in the states of IL, PR, CA, OR, MI, FL, NY, TX, OK, GA, VA and country of CHILE

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040391TOTAL BILIRUBIN REAGENT SETPointe Scientific, Inc., · 2004-06-02

Official Source

View FDA Recall →

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

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