Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass via

FDA device recall Z-2121-2017 · posted 2017-05-20 · Terminated

Recall details

Recalling firm

Medtest Holdings, Inc.

Reason for recall

The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

Action taken

Customers were notified on 05/5/14by sending a technical bulletin (via email, fax, US Mail and posting on website) to all customers and distributors that had received lot 303104 of C7590, lot 303105 of C7591 or C7592 kits with either lot since product was approved to ship. All product shipped after 05/15/2014 included the updated package inserts. Any questions concerning the implementation of the new controls ranges may be directed to Pointe Scientific's Technical Service Department at 1-800-757-5313. Thank you for your continued support of Pointe Scientific.

Root cause

Component design/selection

Status

Terminated

Product code

JJY

Quantity affected

132919 Vol vials

Distribution

Nationwide

Date initiated

2014-05-15

Date posted

2017-05-20

Date terminated

2017-06-02

Location

Canton, MI