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
FDA Recall Z-2631-2017 · Posted 2017-06-26
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Recalling FirmMedtest Holdings, Inc.
Recall StatusTerminated
Product CodeDCK
Date Initiated2009-07-21
Date Terminated2017-07-24
Product Quantity323 vials
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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