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.
Recall
- Recall Number
- Z-1041-2010
- Event Number
- 53784
- Firm
- Pointe Scientific, Inc.
- FEI Number
- 1827821
- Product Code
- CIC
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- November 10, 2009
- Posted
- March 10, 2010
- Terminated
- December 10, 2010
- Address
- 5449 Research Dr, Canton, MI, 48188
Description
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.
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
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.
Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
44 sets