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.
This recall has been terminated (originally issued March 10, 2010).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- November 10, 2009
- Posted
- March 10, 2010
- Terminated
- December 10, 2010
- Recall Number
- Z-1041-2010
- Quantity
- 44 sets
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Distribution
Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
Lot / Code Info
All lots containing 813401 as part of the lot number.
Root Cause
Process control
Action Taken
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.