Recall Z-2631-2017 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Medtest Holdings, Inc.
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 Sci
| Date | Jun 26, 2017 (initiated Jul 21, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 323 vials |
| Distribution | Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT Denka Seiken Co., Ltd., Jun 2, 2003 |