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U.S. Department of Health and Human Services

Class 3 Device Recall Pointe Scientific CRP(HS) Wide Range Control and Wide Range Standard Set

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  Class 3 Device Recall Pointe Scientific CRP(HS) Wide Range Control and Wide Range Standard Set see related information
Date Initiated by Firm July 21, 2009
Date Posted June 26, 2017
Recall Status1 Terminated 3 on July 24, 2017
Recall Number Z-2631-2017
Recall Event ID 77451
510(K)Number K030545  
Product Classification C-reactive protein, antigen, antiserum, and control - Product Code DCK
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
Code Information 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.
Recalling Firm/
Manufacturer		 Medtest Holdings, Inc.
5449 Research Dr
Canton MI 48188-2261
For Additional Information Contact Customer Support
800-445-9853
Manufacturer 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 2		 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 in Commerce 323 vials
Distribution Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DCK and Original Applicant = DENKA SEIKEN CO., LTD.
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