Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
FDA Recall Z-1041-2010 · Posted 2010-03-10
Advertisement
Recalling FirmPointe Scientific, Inc.
Recall StatusTerminated
Product CodeCIC
Date Initiated2009-11-10
Date Terminated2010-12-10
Product Quantity44 sets
Reason for Recall
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Firm Action
Consignees were notified by "Urgent: Medical Device Recall" letter dated November 11, 2009 and instructed to conduct a recall to the retail level, that users should dispose of the product immediately, and that a business reply card should be returned to account for products. If you have any questions, please call Pointe Scientific, Inc. Technical Support Department at 1-800-757-5313 or 1-734-487-8300.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
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.
Advertisement