Recall Z-1041-2010
Pointe Scientific, Inc. · initiated November 10, 2009
Product
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.
Codes / lots: All lots containing 813401 as part of the lot number.
Reason for recall
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
FDA-determined 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.
Details
- Recall number
- Z-1041-2010
- Initiated
- November 10, 2009
- Posted by FDA
- March 10, 2010
- Terminated
- December 10, 2010
- Product code
- CIC – Cresolphthalein Complexone, Calcium
- Quantity
- 44 sets
- Distribution
- Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).
- Recalling firm
- Pointe Scientific, Inc., Canton, MI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1042-2010 | Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set…Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this… | 11/10/2009Terminated |
| Z-1043-2010 | Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set…Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this… | 11/10/2009Terminated |