Pointe Scientific, Inc. Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.
Brand
Pointe Scientific, Inc.
Lot Codes / Batch Numbers
All lots containing 813401 as part of the lot number.
Products Sold
All lots containing 813401 as part of the lot number.
Pointe Scientific, Inc. is recalling Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set, Pointe Scienti due to Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026