Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2

FDA device recall Z-2631-2017 · posted 2017-06-26 · Terminated

Recall details

Recalling firm

Medtest Holdings, Inc.

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.

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.

Root cause

Error in labeling

Status

Terminated

Product code

DCK

Quantity affected

323 vials

Distribution

Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE

Date initiated

2009-07-21

Date posted

2017-06-26

Date terminated

2017-07-24

Location

Canton, MI

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