Liquid AutoHDL Cholesterol Reagent Set, Manufactured for Pointe Scientific, Inc.; Catalog Nos. HH945-240, HH945-480, H7545-40, H7545-80, H7545-320 and H7545-1000. A homogeneous method for the direct determination of high density lipoprotein (HDL) cholesterol in serum or plasma.
FDA Recall Z-1454-06 · Posted 2006-08-30
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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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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