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Terminated

AutoHDL Cholesterol R1 Reagent Set, a homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma, Manufactured for Pointe Scientific, Inc.; Catalogs HH445-R1.

FDA Recall Z-1456-06 · Posted 2006-08-30

Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCCH
Date Initiated2006-06-12
Date Terminated2007-11-19
Product QuantityTo be determined

Reason for Recall

Unexpected changes in QC and proficiency results due to QC and proficiency material matrix.

Firm Action

Consignees were notified via recall letter dated 6/12/06 to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International accounts were notified via email.

Root Cause

Other

Distribution Pattern

Worldwide-USA and Greece, India, Korea, Lebanon, Pakistan, Poland, Singapore, Trinidad, Turkey, United Arab Emirates and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K992002AUTOHDL CHOLESTEROL REAGENT SETPointe Scientific, Inc., · 1999-08-05

Official Source

View FDA Recall →

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

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