Recall Z-2631-2017
Medtest Holdings, Inc. · initiated July 21, 2009
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
Codes / lots: Model #'s C7568-CTL and C7568-STD Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.
Reason for recall
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
FDA-determined cause: Error in labeling
Action taken
Technical Bulletin sent notification on July 21, 2009, to affected consignees via e-mail, fax and US Mail. The recall notification included a description of the reason for the recall, affected product, and consignee responsibilities. Customers with questions were instructed to contact Pointe Scientific's Technical Service Department at 1-800-757-5313. For questions regarding this recall call 800-757-5313.
Details
- Recall number
- Z-2631-2017
- Initiated
- July 21, 2009
- Posted by FDA
- June 26, 2017
- Terminated
- July 24, 2017
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Quantity
- 323 vials
- Distribution
- Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
- Recalling firm
- Medtest Holdings, Inc., Canton, MI